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Rationale and design of the improving Care for Cardiovascular Disease in China (CCC) project: a national registry to improve management of atrial fibrillation.

ABSTRACT: INTRODUCTION:Inadequate management of patients with atrial fibrillation (AF) has been reported in China for anticoagulation therapy and treatment for concomitant diseases. An effective quality improvement programme has been lacking to promote the use of evidence-based treatments and improve outcome in patients with AF. METHODS AND ANALYSIS:The Improving Care for Cardiovascular Disease in China-AF programme is a collaboration of the American Heart Association and the Chinese Society of Cardiology. This programme is designed to promote adherence to AF guideline recommendations and outcomes for inpatients with AF. Launched in February 2015, 150 hospitals are recruited by geographic-economic regions across 30 provinces in China. Each month, 10-20 inpatients with AF are enrolled in each hospital. A web-based data collection platform is used to collect clinical information for patients with AF, including patients' demographics, admission information, medical history, in-hospital care and outcomes, and discharge medications for managing AF. The quality improvement initiative includes monthly benchmarked reports on hospital quality, training sessions, regular webinars and recognitions of hospital quality achievement. Primary analyses will include adherence to performance measures and guidelines. To address intrahospital correlation, generalised estimating equation models will be applied. As of March 2017, 28 801 AF inpatients have been enrolled. ETHICS AND DISSEMINATION:This study protocol was approved by the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University. Results will be published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER:NCT02309398.

SUBMITTER: Hao Y

PROVIDER: S-EPMC6135416 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Rationale and design of the improving Care for Cardiovascular Disease in China (CCC) project: a national registry to improve management of atrial fibrillation.

Hao Yongchen Y Liu Jing J Smith Sidney C SC Huo Yong Y Fonarow Gregg C GC Ge Junbo J Liu Jun J Taubert Kathryn A KA Morgan Louise L Guo Yang Y Zhou Mengge M Zhao Dong D Ma Changsheng C

BMJ open 20180705 7

<h4>Introduction</h4>Inadequate management of patients with atrial fibrillation (AF) has been reported in China for anticoagulation therapy and treatment for concomitant diseases. An effective quality improvement programme has been lacking to promote the use of evidence-based treatments and improve outcome in patients with AF.<h4>Methods and analysis</h4>The Improving Care for Cardiovascular Disease in China-AF programme is a collaboration of the American Heart Association and the Chinese Societ ...[more]

PMID: 29980544

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Project description:BACKGROUND:Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited. OBJECTIVE:The aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. METHODS:A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. RESULTS:Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. CONCLUSIONS:This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. TRIAL REGISTRATION:ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX). REGISTERED REPORT IDENTIFIER:RR1-10.2196/8523.

Project description:IntroductionAtrial fibrillation (AF) is characterised by a high stroke risk. Vitamin K antagonists (VKAs) are the most commonly used oral anticoagulants (OACs) in Spain, but their efficacy and safety depend on the time in therapeutic range of International Normalized Ratio (INR) 2.0-3.0 over 65%-70%. Unfortunately, the difficulties of maintaining an optimal level of anticoagulation and the complications of VKAs (particularly haemorrhagic ones), frequently lead to cessation of this therapy, which has been associated with higher risk of adverse events (AEs), including ischaemic stroke. Our aims are as follows: (1) to evaluate the quality of oral anticoagulation with VKAs, the prevalence of poor quality of anticoagulation, and to identify factors predisposing to poor quality anticoagulation; and (2) to identify patients who will stop OAC and to investigate what factors influence the decision of OAC withdrawal.Methods and analysisProspective observational cohort study including outpatients newly diagnosed with AF and naïve for OACs from July 2016 to June 2018 in an anticoagulation clinic. Patients with prosthetic heart valves, rheumatic mitral valves or valvular AF will be excluded. Follow-up will extend for up to 3 years. During this period, the INR results and changes in the anticoagulant therapy will be recorded, as well as all AEs, or any other information that would be relevant to the proper conduct of research.Ethics and disseminationAll patients were informed about the nature and purpose of the study, and the protocol was approved by the Ethics Committee of Hospital General Universitario Morales Meseguer (reference: EST:20/16). This is an observational study focusing on 'real life' practice and therefore all treatments and follow-up will be performed in accordance to the routine clinical practice with no specific interventions or visits. The results of our study will be disseminated by presentations at national and international meetings, and publications in peer-reviewed journals.

Dataset Information

Rationale and design of the improving Care for Cardiovascular Disease in China (CCC) project: a national registry to improve management of atrial fibrillation.

Publications

Rationale and design of the improving Care for Cardiovascular Disease in China (CCC) project: a national registry to improve management of atrial fibrillation.

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