ResearchPad - 1683 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Efficacy and safety of xuezhikang once per day versus two times per day in patients with mild to moderate hypercholesterolaemia (APEX study): a protocol for a multicentre, prospective randomised controlled, open-label, non-inferiority study]]> https://www.researchpad.co/article/elastic_article_12537 Reduction in low-density lipoprotein cholesterol (LDL-C) improves clinical outcomes in patients with coronary artery disease. However, rates of lipid-lowering medication adherence are far from ideal. Reducing dosage frequency from multiple dosing to once-daily dosing may improve patients’ medication adherence. Xuezhikang (XZK), an extract of Chinese red yeast rice, contains a family of naturally occurring statins and is traditionally prescribed as 600 mg two times per day. A comParative Efficacy study of XZK (APEX study) is designed to test the hypothesis that XZK prescribed 1200 mg once per day (OD group) is non-inferior to 600 mg two times per day (TD group) in patients with hypercholesterolaemia.Methods and analysisThe APEX study is a multicentre, prospective randomised controlled, open-label, non-inferiority study. We plan to recruit 316 patients aged ≥18 years with a diagnosis of mild to moderate hypercholesterolaemia for primary prevention. Patients will be randomised (1:1) to OD group and TD group. The OD group take XZK 1200 mg once per day after dinner while TD group take a traditional dose of 600 mg, two times per day after meals. Participants will have an 8-week medication period and be followed up at weeks 0, 4 and 8. The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance. Data analyses will be on the intention-to-treat principle using non-inferiority analysis.Ethics and disseminationThe research had been approved by the Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University ((2017)286). The results will be reported through peer-reviewed journals, seminars and conference presentations.Trial registration numberChiCTR-IIR-17013660. ]]> <![CDATA[Age-related trends in lipid levels: a large-scale cross-sectional study of the general Chinese population]]> https://www.researchpad.co/article/elastic_article_9092 This study aimed to investigate the dynamic trends in total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) levels with ageing.DesignA Chinese population-based cross-sectional study.SettingA physical examination centre of a general hospital.ParticipantsAdult subjects (178 167: 103 461 men and 74 706 women) without a known medical history or treatments that affect lipid metabolism.Main outcome measuresDynamic trends in the above-mentioned lipid parameters with ageing were explored; turning points of age were established using age stratification and validated by fitted multivariate linear regression modelling.ResultsAge was found to be an independent factor extensively associated with lipid levels in both sexes when adjusted for serum glucose, body mass index, lifestyle, drinking and smoking. Age was positively associated with TC, logarithm-transformed TG (LnTG) and LDL-C levels in men ≤40, ≤40 and ≤60 years old (yo) and in women ≤60, ≤70 and ≤60 yo, respectively. Conversely, age correlated negatively with TC, LnTG and LDL-C levels in men ≥61, ≥41 and ≥61 yo and in women ≥61, ≥71 and ≥61 yo, respectively. TC, TG and LDL-C levels in women were initially lower than those in men but surpassed those in men in 51–55, 61–65 and 51–55 yo age groups. The trends in HDL-C levels with age were relatively irregular, although HDL-C levels in women were higher than in men for all age groups.ConclusionsThe definition of dyslipidaemia, the atherosclerotic cardiovascular disease risk assessment and the initiation/goals of statin therapy should fully consider age-related trends in lipid levels and sex differences. ]]> <![CDATA[Text messages for primary prevention of cardiovascular disease: the TextMe2 randomised controlled trial protocol]]> https://www.researchpad.co/article/N75362589-ae67-4329-bf99-a4d2439bac03 Mobile health may be an effective means of delivering customised individually directed health promotion interventions for cardiovascular disease (CVD) primary prevention. The aim of this study is to evaluate the effectiveness of a lifestyle-focused text messaging programme for primary CVD prevention.Methods and analysisSingle-blind randomised controlled trial with 6 months’ follow-up in 246 patients with moderate-high absolute cardiovascular risk and without coronary heart disease recruited from a rapid access cardiology clinic. Participants will be randomised to receive either usual care or TextMe2 (text message-based prevention programme). The TextMe2 programme provides support, motivation and education on five topics: diet, physical activity, smoking, general cardiovascular health and medication adherence, and is delivered in four text messages per week over 6 months. The primary outcome is change in the proportion of patients who have three or more of five key modifiable risk factors that are uncontrolled (low-density lipoprotein >2.0 mmol/L, systolic blood pressure >140 mm Hg, body mass index >24.9 kg/m2, physical activity (less than the equivalent of 150 min of moderate intensity each week), current smoker). Secondary outcomes are changes in single biomedical risk factors, behavioural risk factors, quality of life, depression/anxiety scores, medication adherence, cardiovascular health literacy and hospital readmissions/representations. Analysis will be according to the intention-to-treat principle and full statistical analysis plan developed prior to data lock.Ethics and disseminationThis study has been approved by the Western Sydney Local Health District Human Research Ethics Committee at Westmead (AU/RED/HREC/17/WMEAD/186). Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberACTRN12618001153202. ]]> <![CDATA[Coronary artery disease prediction in women and men using chest pain characteristics and risk factors: an observational study in outpatient clinics]]> https://www.researchpad.co/article/N757c6b79-0a26-4dfa-8917-d097f0d22d03 To assess the diagnostic value of non-acute chest pain characteristics for coronary artery disease in women and men referred to outpatient cardiology clinics.Design and settingThis is an observational study performed at outpatient cardiology centres of the Netherlands.ParticipantsThe study population consisted of 1028 patients with non-acute chest pain (505 women).Analysis and resultsTwenty-four women (5%) and 75 men (15%) were diagnosed with coronary artery disease by invasive coronary angiography or CT angiography during regular care follow-up. Elastic net regression was performed to assess which chest pain characteristics and risk factors were of diagnostic value. The overall model selected age, provocation by temperature or stress, relief at rest and functional class as determinants and was accurate in both sexes (area under the curve (AUC) of 0.76 (95% CI 0.68 to 0.85) in women and 0.83 (95% CI 0.78 to 0.88) in men). Both sex-specific models selected age, pressuring nature, radiation, duration, frequency, progress, provocation and relief at rest as determinants. The female model additionally selected dyspnoea, body mass index, hypertension and smoking while the male model additionally selected functional class and diabetes. The sex-specific models performed better than the overall model, but more so in women (AUC: 0.89, 95% CI 0.81 to 0.96) than in men (AUC: 0.84, 95% CI 0.73 to 0.90).ConclusionsIn both sexes, the diagnostic value of non-acute chest pain characteristics and risk factors for coronary artery disease was high. Provocation, relief at rest and functional class of chest pain were the most powerful diagnostic predictors in both women and men. When stratified by sex the performance of the model improved, mostly in women. ]]> <![CDATA[Cardiac arrest after pulmonary aspiration in hospitalised patients: a national observational study]]> https://www.researchpad.co/article/N79ced341-3b99-444c-81f9-ec3da76a141f

Objective

To study characteristics and outcomes among patients with in-hospital cardiac arrest (IHCA) due to pulmonary aspiration.

Design

A retrospective observational study based on data from the Swedish Registry of Cardiopulmonary Resuscitation (SRCR).

Setting

The SRCR is a nationwide quality registry that covers 96% of all Swedish hospitals. Participating hospitals vary in size from secondary hospitals to university hospitals.

Participants

The study included patients registered in the SRCR in the period 2008 to 2017. We compared patients with IHCA caused by pulmonary aspiration (n=127), to those with IHCA caused by respiratory failure of other causes (n=2197).

Primary and secondary outcome measures

Primary outcome was 30-day survival. Secondary outcome was sustained return of spontaneous circulation (ROSC) defined as ROSC at the scene and admitted alive to the intensive care unit.

Results

In the aspiration group 80% of IHCA occurred on general wards, as compared with 63.6% in the respiratory failure group (p<0.001). Patients in the aspiration group were less likely to be monitored at the time of the arrest (18.5% vs 38%, p<0.001) and had a significantly lower rate of sustained ROSC (36.5% vs 51.6%, p=0.001). The unadjusted 30-day survival rate compared with the respiratory failure group was 7.9% versus 18.0%, p=0.024. In a propensity score analysis (including variables; year, age, gender, location of arrest, initial heart rhythm, ECG monitoring, witnessed collapse and a previous medical history of; cancer, myocardial infarction or heart failure) the OR for 30-day survival was 0.46 (95% CI 0.19 to 0.94).

Conclusions

In-hospital cardiac arrest preceded by pulmonary aspiration occurred more often on general wards among unmonitored patients. These patients had a lower 30-day survival rate compared with IHCA caused by respiratory failure of other causes.

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<![CDATA[Effect of resting heart rate on the risk of all-cause death in Chinese patients with hypertension: analysis of the Kailuan follow-up study]]> https://www.researchpad.co/article/Nb20293ae-084d-4099-99b9-da5adce3ea4a

Objective

Previous studies have shown that an elevated heart rate is associated with a higher risk of cardiovascular events. This study aimed to prospectively examine the relationship between resting heart rate (RHR) and all-cause mortality in Chinese patients with hypertension.

Design

An observational, prospective and population-based cohort study.

Setting

The Kailuan cohort study was conducted in Tangshan City in northern China.

Participants

We enrolled 46 561 patients who did not receive beta-blocker treatment and were diagnosed with hypertension for the first time during an employee health examination in Kailuan Group in 2006 and 2008.

Outcome

The primary outcome of this study was all-cause mortality.

Methods

The patients in this study were followed for 9.25±1.63 years. All patients were followed up face to face every 2 years. According to the distribution of RHR in the study population, RHR was categorised into five groups on the basis of quintiles: Q1: RHR ≤68 beats per minute (bpm); Q2: RHR >68 and ≤72 bpm; Q3: RHR >72 and ≤76 bpm; Q4: RHR >76 and ≤82 bpm; Q5: RHR >82 bpm. Cox proportional hazards model, which was adjusted for traditional risk factors, was used.

Results

During follow-up, 4751 deaths occurred. After adjustment for potential confounders, restricted cubic spline regression showed that the risk of all-cause mortality increased with heart rate. In multivariate Cox regression analyses adjusted for age, sex and major covariates, the HR for all-cause mortality was 1.31 (95% CI 1.27 to 1.33) in the highest quintile group (Q5) compared with the lowest quintile group (Q1).

Conclusion

An increase in RHR is a long-term risk factor of all-cause mortality in Chinese patients with hypertension.

Trial registration number

ChiCTR-TNC-11001489.

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<![CDATA[Drug use and torsades de pointes cardiac arrhythmias in Sweden: a nationwide register-based cohort study]]> https://www.researchpad.co/article/N8d457181-a9a4-4238-8558-10896e65a738

Objective

To study the occurrence of torsades de pointes (TdP) ventricular tachycardia in relation to use of drugs labelled with TdP risk, using two nationwide Swedish registers.

Design

Prospective register-based cohort study.

Setting

Entire Sweden.

Participants

Persons aged ≥18 years prescribed and dispensed any drug classified with TdP risk during 2006–2017, according to CredibleMeds. Persons with a registered TdP diagnosis during the study period, using drugs labelled with known (TdP 1), possible (TdP 2) or conditional (TdP 3) risk at the incident of TdP were examined.

Primary outcome measures

Occurrence of TdP in relation to exposure rates for individual drugs with TdP risk.

Secondary outcome measures

Concurrent use of more than one TdP-labelled drug in a person with a TdP diagnosis.

Results

During the study period, 410 TdP cases using drugs with TdP risk labels at the incident were registered; 205 women and 205 men, mean age 74.0 and 71.5 years, respectively. Antidepressants dominated (129/410, 30%), followed by antiarrhythmics (17%). Diuretics and gastric acid-secretion inhibitors, with TdP risk related to induction of hypokalaemia or hypomagnesaemia, were used in 56% and 32% of the 410 TdP cases, respectively. Among the most used antidepressants, citalopram with known TdP 1 risk was associated with both a higher absolute number and incidence of TdP per 100 000 users (two to four times), compared with mirtazapine with possible (TdP 2), and sertraline with conditional (TdP 3) risk. Multiple risk factors, including advanced age, cardiovascular disease and treatment with more than one TdP-classified drug, were frequently observed.

Conclusions

Antidepressants followed by antiarrhythmics dominated among TdP risk drugs used by adults with TdP diagnosis, the majority being ≥65 years. TdP risk class and concomitant medication should be considered when prescribing antidepressants to older patients.

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<![CDATA[Development and usability testing of HEARTPA♀N: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain]]> https://www.researchpad.co/article/N2f86e1ba-cf05-489f-939c-c9cecee36bc8

Introduction

More women experience cardiac pain related to coronary artery disease and cardiac procedures compared with men. The overall goal of this programme of research is to develop an integrated smartphone and web-based intervention (HEARTPA♀N) to help women recognise and self-manage cardiac pain.

Methods and analysis

This protocol outlines the mixed methods strategy used for the development of the HEARTPA♀N content/core feature set (phase 2A), usability testing (phase 2B) and evaluation with a pilot randomised controlled trial (RCT) (phase 3). We are using the individual and family self-management theory, mobile device functionality and pervasive information architecture of mHealth interventions, and following a sequential phased approach recommended by the Medical Research Council to develop HEARTPA♀N. The phase 3 pilot RCT will enable us to refine the prototype, inform the methodology and calculate the sample size for a larger multisite RCT (phase 4, future work). Patient partners have been actively involved in setting the HEARTPA♀N research agenda, including defining patient-reported outcome measures for the pilot RCT: pain and health-related quality of life (HRQoL). As such, the guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols (SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3). Quantitative data (eg, demographic and clinical information) will be summarised using descriptive statistics (phases 2AB and 3) and a content analysis will be used to identify themes (phase 2AB). A process evaluation will be used to assess the feasibility of the implementation of the intervention and a preliminary efficacy evaluation will be undertaken focusing on the outcomes of pain and HRQoL (phase 3).

Ethics and dissemination

Ethics approval was obtained from the University of Toronto (36415; 26 November 2018). We will disseminate knowledge of HEARTPA♀N through publication, conference presentation and national public forums (Café Scientifique), and through fact sheets, tweets and webinars.

Trial registration number

NCT03800082.

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<![CDATA[Sex differences in the efficacy of antihypertensive treatment in preventing cardiovascular outcomes and reducing blood pressure: protocol for a systematic review and meta-analysis]]> https://www.researchpad.co/article/N2cf8d28f-9b43-440b-9eea-ad348cce9445

Introduction

Hypertension is a leading cause of mortality worldwide and its prevalence is expected to rise over the next decade. Sex differences exist in the epidemiology and pathophysiology of hypertension. It is well established that antihypertensive treatment can significantly reduce the risk for stroke and other cardiovascular disease events. However, it remains unclear whether this effect is dependent on sex. In this protocol, we outlined a systematic review and meta-analysis to evaluate the effects of antihypertensive therapy in (1) reducing blood pressure and (2) preventing cardiovascular morbidity and mortality outcomes for each sex separately.

Methods and analysis

The following electronic databases will be searched: Medline, Embase, The Cochrane Library, PubMed, Cumulative Index of Nursing and Allied Health Literature Plus, Web of Science, grey literature (Google Scholar) and several trial registries. Search strategies will be designed to identify human adult (≥18) randomised (and non-randomised) controlled trials, prospective and retrospective cohort studies, and case–control studies concerning ‘sex-specific differences associated with the efficacy of antihypertensive treatment’. A preliminary search strategy was developed for Medline (1946—16 September 2019). Two investigators will independently review each article included in the final analysis. Primary outcomes investigated are cardiovascular morbidity and mortality and systolic and diastolic blood pressure. Pooled analyses will be conducted using the random-effects model. Publication bias will be assessed by visual inspection of funnel plots and by Begg’s and Egger’s statistical tests. Between-studies heterogeneity will be measured using the I2 test (p<0.10). Sources of heterogeneity will be explored by sensitivity, subgroup and metaregression analyses.

Ethics and dissemination

This is the first meta-analysis that will comprehensively compare the efficacy of antihypertensive treatment regimens between men and women. Findings will be shared through scientific conferences and societies, social media and consumer advocacy groups. Results will be used to inform the current guidelines for management of hypertension in men and women by demonstrating the importance of implementing sex-specific recommendations. Ethical considerations are not applicable for this protocol.

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<![CDATA[Impact of sex and myocardial function on association of obesity with mortality in Asian patients with acute heart failure: a retrospective analysis from the STRATS-AHF registry]]> https://www.researchpad.co/article/N4f306d91-98e2-4474-b7e3-74b5ba4e2d29

Objectives

Impact of sex and myocardial function on the obesity paradox in heart failure (HF) is unknown. We explored whether sex, myocardial function, and left ventricular (LV) geometry explains the protective association of body mass index (BMI) with mortality, and investigated whether metabolic health status affects this association.

Design

A multicentre cohort study with patients with acute HF admitted from January 2009 to December 2016 with a median follow-up of 33.7 months.

Setting

Three tertiary hospitals.

Participants

A total of 2021 overweight-to-obese (OW) and 1543 normal-weight (NW) patients with acute HF.

Measurements

The primary outcome was all-cause mortality. Patients were categorised as either OW (BMI≥23kg/m2) or NW (BMI<23kg/m2). BMI was used as both categorical and continuous variables. Clinical, laboratory and echocardiographic measures, including LV global longitudinal strain (LV-GLS), LV-ejection fraction, LV geometry, were obtained.

Results

During the follow-up period, 1392 patients died (685 OW and 707 NW). BMI was significantly associated with mortality in univariate (HR=0.929 per kg/m2, p<0.001) and multivariate analyses (HR=0.954 per kg/m2, p<0.001). In multivariable fractional polynomials, higher BMIs were associated with lower mortality overall and in subgroups by sex, LV-GLS and LV geometry, with a steeper association in men (p-interaction <0.001). In women, there were significant interactions of BMI with LV-GLS (p-interaction=0.044) and age (p-interaction=0.040) for mortality; the protective association of BMI with mortality was confined to subgroups with high LV-GLS (>10.1%) or elderly patients (≥75 years). In men, this association was found in all subgroups without significant interaction. Metabolically healthy obese patients had better survival than metabolically unhealthy obese patients (log-rank p<0.001).

Conclusions

In women, a significant interaction was observed between BMI and age or LV-GLS in association with mortality, suggesting that sex, ageing and myocardial dysfunction can affect the magnitude of the obesity paradox in HF. Metabolic health status provides prognostic information beyond obesity status.

Trial registration number

Registry: ClinicalTrials.gov Number: NCT03513653 (https://clinicaltrials.gov/ct2/show/NCT03513653)

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<![CDATA[Randomised, double-blind, placebo-controlled clinical trial investigating the effects of inorganic nitrate in hypertension-induced target organ damage: protocol of the NITRATE-TOD study in the UK]]> https://www.researchpad.co/article/Nf7f03d83-7529-420d-a261-307689f0accb

Introduction

Arterial stiffness and left ventricular (LV) hypertrophy are the key markers of hypertensive target organ damage (TOD) associated with increased cardiovascular morbidity and mortality. We have previously shown that dietary inorganic nitrate supplementation lowers blood pressure (BP) in hypertension, however, whether this approach might also improve markers of hypertensive TOD is unknown. In this study, we will investigate whether daily dietary inorganic nitrate administration reduces LV mass and improves measures of arterial stiffness.

Methods and design

NITRATE-TOD is a double-blind, randomised, single-centre, placebo-controlled phase II trial aiming to enrol 160 patients with suboptimal BP control on one or more antihypertensives. Patients will be randomised to receive 4 months once daily dose of either nitrate-rich beetroot juice or nitrate-deplete beetroot juice (placebo). The primary outcomes are reduction in LV mass and reduction in pulse wave velocity (PWV) and central BP.

The study has a power of 95% for detecting a 9 g LV mass change by cardiovascular MRI (~6% change for a mildly hypertrophied heart of 150 g). For PWV, we have a power of >95% for detecting a 0.6 m/s absolute change. For central systolic BP, we have a>90% power to detect a 5.8 mm Hg difference in central systolic BP.

Secondary end points include change in ultrasound flow-mediated dilation, change in plasma nitrate and nitrite concentration and change in BP.

Ethics and dissemination

The study was approved by the London—City and East Research Ethics Committee (10/H0703/98). Trial results will be published according to the Consolidated Standards of Reporting Trials statement and will be presented at conferences and reported in peer-reviewed journals.

Trial registration number

NCT03088514

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<![CDATA[Association between cardiovascular risk factors and coronary artery disease assessed using CAD-RADS classification: a cross-sectional study in Romanian population]]> https://www.researchpad.co/article/N0164662f-4151-4870-9129-16614036f0b5

Objectives

This study aimed to evaluate the association between cardiovascular risk factors and Coronary Artery Disease—Reporting and Data System (CAD-RADS) score in the Romanian population. CAD-RADS is a new, standardised method to assess coronary artery disease (CAD) using coronary CT angiography (CCTA).

Design

A cross-sectional observational, patient-based study.

Setting

Referred imaging centre for CAD in Transylvania, Romania.

Participants

We retrospectively reviewed 674 patients who underwent CCTA between January 2017 and August 2018. The exclusion criteria included: previously known CAD, defined as prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery (n=91), cardiac CT for other than evaluation of possible CAD (n=85), significant arrhythmias compromising imaging quality (n=23). Finally, 475 patients fulfilled the inclusion criteria.

Methods

Demographical, clinical and CCTA characteristics of the patients were obtained. CAD was evaluated using CAD-RADS score. Obstructive CAD was defined as ≥50% stenosis of ≥1 coronary segment on CCTA.

Results

We evaluated the association between risk factors and CAD-RADS score in univariate and multivariable analysis. We divided the patients into two groups according to the CAD-RADS system: group 1: CAD-RADS score between 0 and 2 (stenosis <50%) and group 2: CAD-RADS score ≥3 (stenosis ≥50%). On univariate analysis, male gender, age, hypertension, dyslipidaemia, smoking and diabetes mellitus were positively associated with a CAD-RADS score ≥3. The multivariate analysis showed that male sex, age, dyslipidaemia, hypertension and smoking were independently associated with obstructive CAD.

Conclusion

This study demonstrated a significant association between multiple cardiovascular risk factors and a higher coronary atherosclerotic burden assessed using CAD-RADS system in the Romanian population.

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<![CDATA[Internal deterministic record linkage using indirect identifiers for matching of same-patient hospital transfers and early readmissions after acute coronary syndrome in a nationwide hospital discharge database: a retrospective observational validation study]]> https://www.researchpad.co/article/N46f0c562-3999-4386-b2b4-7fc236a61ea6

Objectives

To assess validity of record linkage using multiple indirect personal identifiers to identify same-patient hospitalisations and definition of episode of care (EC) due to acute coronary syndrome (ACS).

Methods

Using national hospital discharge data to identify all admissions due to ACS, we used six different linkage rules using indirect identifiers with increasing level of detail and compared validity against a pseudonymised unique identifier used as gold standard (GS). Contiguous hospitalisations within each matched group of hospitalizations occurring within 28 days of each other were considered one EC. We classified hospitalisations according to time between the first pair of hospitalisations as hospital transfer (HT: ≤1 day), early readmission (ER: 2–28 days) or recurrent cases (>28 days).

Results

There were 146 671 hospitalisations (unlinked), 121 987 ACS 28-day EC (linked GS), with 18 398 HTs (≤1 day), and 6286 ERs (≤28 days). Linkage rules using demographic and residence code variables produced linkage rates with highest validity for rule using sex, date of birth and four-digit residence code with sensitivity of 98.4 (95% CI: 98.4 to 98.5); specificity of 97.8 (95% CI: 97.6 to 98.0) and Cohen’s κ of 0.9 to detect ACS-EC, compared with GS linkage rule. Similarly, validity for HT and ER was high and of similar magnitude, with sensitivity ranging between 97.2% and 98.1%, and specificity between 98.8% and 99.9%, respectively.

Conclusions

Our internal linkage validation study using indirect patient identifiers will allow calibration of incidence rates and performance indicators, accounting for the effect of HT and readmissions.

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<![CDATA[Experiences of informal caregivers after cardiac surgery: a systematic integrated review of qualitative and quantitative studies]]> https://www.researchpad.co/article/Nc20ceb83-785b-49d4-a595-e746576b3bf7

Objectives

To provide a comprehensive synthesis of informal caregivers’ experiences of caring for a significant other following discharge from cardiac surgery.

Design

Systematic integrated review without meta-analysis.

Data sources

A bibliographic search for publications indexed in six databases (Cochrane Library, CINAHL, MEDLINE, EMBASE, AMED and PsycINFO), including a scan of grey literature sources (GreyNet International, Google Scholar, Web of Science, WorldCat and the Clinical Trials Registry) was conducted in October 2018.

Eligibility criteria for selecting studies

Studies were included if they described views and perspectives of informal caregivers of cardiac surgery patients (non-intervention studies (qualitative and quantitative)), and the effectiveness of interventions to evaluate support programme for informal caregivers of cardiac surgery patients (intervention studies).

Results

Of the 4912 articles identified in searches, 42 primary research studies were included in a narrative synthesis with 5292 participants, including 3231 (62%) caregivers of whom 2557 (79%) were women. The median sample size across studies was 96 (range 6–734). Three major themes emerged from the qualitative study data: (1) caregiver information needs; (2) caregiver work challenges and (3) caregivers adaption to recovery. Across the observational studies (n=22), similar themes were found. The trend across seven intervention studies focused on caregiver information needs related to patient disease management and symptom monitoring, and support for caregivers to reduce symptoms of emotional distress.

Conclusion

Informal caregivers want to assist in the care of their significant others after hospital discharge postcardiac surgery. However, caregivers feel insecure and overwhelmed and they lack clear/concise discharge information and follow-up support during the early at-home recovery period. The burden of caregiving has been recognised and reported since the early 1990s, but there remains a limited number of studies that assesses the effectiveness of caregiver interventions.

PROSPERO registration number

CRD42018096590.

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<![CDATA[Occurrence and mortality of vasospastic angina pectoris hospitalised patients in Finland: a population-based registry cohort study]]> https://www.researchpad.co/article/N5ce3c3f1-a68d-4571-83d1-4b64fed742d9

Objectives

The occurrence and mortality of vasospastic angina pectoris (VAP) is largely unknown in western countries. Our objective was to clarify the occurrence, gender-distribution and mortality of VAP in Finland using a population-based hospital registry.

Methods

We studied consecutive patients aged ≥18 years hospitalized with VAP as the primary cause of admission in Finland during 2004–2014. The data were collected from obligatory nationwide registries. During the study period 1762 admissions were recorded.

Results

Majority of all VAP patients were male (59.7%) and mean age was 65.7±12.0 years. Annual admission rate for VAP was 2.29/100 000 person-years. Men were in higher risk for VAP than women (admission rate 3.00/100 000 vs 1.68/100 000; RR 1.70; p<0.0001). Gender difference was not modified by age. Likelihood of VAP was highest in population aged 70–84 years. Admission rate for VAP decreased notably during the study period. One-year all-cause mortality was 8.0% and 3-year mortality was 15.5% (cardiac mortality 11.1%). Mortality was associated with increasing age, comorbidity burden and lack of detected coronary artery obstruction, but was similar between genders and during the study period.

Conclusions

Men have higher risk for vasospastic angina caused admissions. Likelihood of vasospastic angina admission was highest in aged population. The 3-year all-cause mortality was 15.5%. Mortality was associated with increasing age, comorbidities and non-obstructive VAP diagnosis but was similar between genders.

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<![CDATA[Clot regression effects of rivaroxaban in the treatment of venous thromboembolism in patients with cancer (CRERIT-VTE cancer): study protocol]]> https://www.researchpad.co/article/N9d7ea812-74c6-4e14-a52d-fc1586962211

Introduction

Anticoagulant therapy in patients with cancer with venous thromboembolism (VTE) increases the risk of both VTE recurrence and haemorrhagic complication. Direct oral anticoagulants (DOACs) have been shown to be effective in preventing VTE recurrence, and comparable to conventional therapy in preventing VTE recurrence in patients with advanced cancer. Rivaroxaban is a DOAC that causes thrombus regression, possibly through a profibrinolytic effect. Thrombus regression with initial treatment is essential for VTE patients. However, the thrombolytic effect of DOAC for VTE patients with cancer has not been fully examined. Therefore, in this study, we investigate the thrombolytic effect of rivaroxaban in patients with cancer who develop VTE.

Methods and analysis

This study is a single-arm, open-label, prospective interventional study. Forty patients aged from 20 to 75 years old at the time of consent who have been diagnosed with acute VTE and have active cancer are included. Patients are excluded if they have received thrombolytic therapy, have creatinine clearance of less than 30 mL/min, have expected a life expectancy of less than 6 months or have deep vein thrombosis limited to the distal lower leg. Eligible patients receive standard treatment with rivaroxaban (15 mg two times daily for 3 weeks, followed by 15 mg QD). The primary study endpoint is clot regression ratio as evaluated by contrast-enhanced CT imaging. CT imaging is obtained at baseline, 21±4 and 90±14 days after the start of rivaroxaban treatment. Secondary endpoints are the recurrence of VTE and haemorrhagic complications.

Ethics and dissemination

This study was approved by the institutional review board of the Kyoto Prefectural University of Medicine. Study results will be disseminated through peer-reviewed journals.

Trial registration number

UMIN000027793

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<![CDATA[Yoga and Cardiovascular Health Trial (YACHT): a UK-based randomised mechanistic study of a yoga intervention plus usual care versus usual care alone following an acute coronary event]]> https://www.researchpad.co/article/N5ca2a821-0e41-4844-8761-696bdc47b329

Objective

To determine the effects of yoga practice on subclinical cardiovascular measures, risk factors and neuro-endocrine pathways in patients undergoing cardiac rehabilitation (CR) following acute coronary events.

Design

3-month, two-arm (yoga +usual care vs usual care alone) parallel randomised mechanistic study.

Setting

One general hospital and two primary care CR centres in London. Assessments were conducted at Imperial College London.

Participants

80 participants, aged 35–80 years (68% men, 60% South Asian) referred to CR programmes 2012–2014.

Intervention

A certified yoga teacher conducted yoga classes which included exercises in stretching, breathing, healing imagery and deep relaxation. It was pre-specified that at least 18 yoga classes were attended for inclusion in analysis. Participants and partners in both groups were invited to attend weekly a 6- to 12-week local standard UK National Health Service CR programme.

Main outcome measures

(i) Estimated left ventricular filling pressure (E/e′), (ii) distance walked, fatigue and breathlessness in a 6 min walk test, (iii) blood pressure, heart rate and estimated peak VO2 following a 3 min step-test. Effects on the hypothalamus–pituitary–adrenal axis, autonomic function, body fat, blood lipids and glucose, stress and general health were also explored.

Results

25 participants in the yoga + usual care group and 35 participants in the usual care group completed the study. Following the 3-month intervention period, E/e′ was not improved by yoga (E/e′: between-group difference: yoga minus usual care:−0.40 (−1.38, 0.58). Exercise testing and secondary outcomes also showed no benefits of yoga.

Conclusions

In this small UK-based randomised mechanistic study, with 60 completing participants (of whom 25 were in the yoga + usual care group), we found no discernible improvement associated with the addition of a structured 3-month yoga intervention to usual CR care in key cardiovascular and neuroendocrine measures shown to be responsive to yoga in previous mechanistic studies.

Trial registration number

NCT01597960; Pre-results.

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<![CDATA[GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study]]> https://www.researchpad.co/article/N77697dc3-b881-4849-9a34-dfa3856097fa

Objectives

To externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort.

Design

Retrospective cohort study.

Setting

Danish nationwide registries.

Participants

90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year.

Primary and secondary outcome measures

External validation was performed using discrimination and calibration plots. C-statistics were compared with CHA2DS2VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes.

Results

Of the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66–83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA2DS2VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60).

Conclusion

In a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA2DS2VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

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<![CDATA[Prehospital and in-hospital delays to care and associated factors in patients with STEMI: an observational study in 101 non-PCI hospitals in China]]> https://www.researchpad.co/article/Nb3bec330-a7f5-4021-972c-f400a9a26182

Objectives

To describe the prehospital and in-hospital delays to care and factors associated with the delays among patients with ST-segment elevation myocardial infarction (STEMI) in non-percutaneous coronary intervention (PCI) hospitals in China.

Design, setting and participants

We analysed data from a large registry-based quality of care improvement trial conducted from 2011 to 2014 among 101 non-PCI hospitals in China. A total of 7312 patients with STEMI were included. Prehospital delay was defined as time from symptom onset to hospital arrival >120 min, first ECG delay as time from arrival to first ECG >10 min, thrombolytic therapy delay as time from first ECG to thrombolytic therapy >10 min and in-hospital delay as time from arrival to thrombolytic therapy >30 min. Logistic regressions with generalised estimating equations were preformed to identify the factors associated with each delay.

Results

The rates of prehospital delay, first ECG delay, thrombolytic therapy delay and in-hospital delay were 67.1%, 31.4%, 85.8% and 67.8%, respectively. Patients who were female, older than 65 years old, illiterate, farmers, onset during late night and forenoon, had heart rate ≥100 beats/m at admission were more likely and patients who had history of myocardial infarction, hypertension or SBP <90 mm Hg at admission were less likely to have prehospital delay. First ECG delay was more likely to take place in patients arriving on regular hours. Thrombolytic therapy delay rate was lower in patients who had prehospital delay or first ECG delay but higher in those with heart rate ≥100 beats/m at admission. In-hospital delay rate was lower in patients with a history of dyslipidaemia and those who arrived during regular hours.

Conclusion

Chinese patients with STEMI in low medical resource areas suffered severe prehospital and in-hospital delays to care. Future efforts should be made to improve the prehospital delay among vulnerable populations with low socioeconomic status.

Trial registration number

NCT01398228; Post-results.

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<![CDATA[Evaluation of a 1-hour troponin algorithm for diagnosing myocardial infarction in high-risk patients admitted to a chest pain unit: the prospective FAST-MI cohort study]]> https://www.researchpad.co/article/Nad6ed165-25f0-4a1d-ab88-3803ed182f51

Objective

This study sought to evaluate the diagnostic performance of the 1-hour troponin algorithm for diagnosis of myocardial infarction (MI) without persistent ST-segment elevations (non-ST-segment MI (NSTEMI)) in a cohort with a high prevalence of MI. This algorithm recommend by current guidelines was previously developed in cohorts with a prevalence of MI of less than 20%.

Design

Prospective cohort study from November 2015 until December 2016.

Setting

Dedicated chest pain unit of a single referral centre.

Participants

Consecutive patients with suspected MI were screened. Patients with subacute symptoms lasting more than 24 hours, new ST-segment elevations at presentation, or an already diagnosed or ruled-out acute MI were excluded. All enrolled patients (n=1317) underwent a full clinical assessment and measurements of high-sensitivity troponin, and were scheduled for an early invasive strategy if clinically indicated.

Main outcome measures

Final diagnosis of MI according to the Fourth Universal Definition of MI.

Results

The prevalence of NSTEMI in the present cohort was 36.9%. The sensitivity for rule-out of MI was 99.8%. The specificity for rule-in of MI was found to be 94.3%. However, in 35.7% of patients neither rule-in nor rule-out was possible. In 51.4% of patients diagnosed with MI, a primary non-coronary reason for MI was found (type 2 MI). Different receiver operating characteristic-curve derived cut-offs for troponin and its dynamics did not provide a sufficient differentiation between type 1 and 2 MI for clinical decision making (negative predictive value for rule-out of type 1 MI <70%).

Conclusions

The 1-hour diagnosis algorithm for patients with suspected NSTEMI can accurately diagnose acute MI in high-risk cohorts. However, discrimination between patients needing an early invasive strategy or not is limited.

Trial registration number

DRKS00009713.

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