The Bangladesh Risk of Acute Vascular Events (BRAVE) Study: objectives and design

The Bangladesh Risk of Acute Vascular Events (BRAVE) Study: objectives and design Rajiv Chowdhury 0 1 2 3 4 Dewan S. Alam 0 1 2 3 4 Ismail Ibrahim Fakir 0 1 2 3 4 Sheikh Daud Adnan 0 1 2 3 4 Aliya Naheed 0 1 2 3 4 Ishrat Tasmin 0 1 2 3 4 Md Mostafa Monower 0 1 2 3 4 Farzana Hossain 0 1 2 3 4 Fatema Mahjabin Hossain 0 1 2 3 4 Md Mostafizur Rahman 0 1 2 3 4 Sadia Afrin 0 1 2 3 4 Anjan Kumar Roy 0 1 2 3 4 Minara Akter 0 1 2 3 4 Sima Akter Sume 0 1 2 3 4 Ajoy Kumer Biswas 0 1 2 3 4 Lisa Pennells 0 1 2 3 4 Praveen Surendran 0 1 2 3 4 Robin D. Young 0 1 2 3 4 Sarah A. Spackman 0 1 2 3 4 Khaled Hasan 0 1 2 3 4 Eric Harshfield 0 1 2 3 4 Nasir Sheikh 0 1 2 3 4 Richard Houghton 0 1 2 3 4 Danish Saleheen 0 1 2 3 4 Joanna MM Howson 0 1 2 3 4 Adam S. Butterworth 0 1 2 3 4 Cardiology Research Group 0 1 2 3 4 Rubhana Raqib 0 1 2 3 4 Abdulla Al Shafi Majumder 0 1 2 3 4 John Danesh 0 1 2 3 4 Emanuele Di Angelantonio 0 1 2 3 4 0 National Institute of Cardiovascular Disease , Dhaka , Bangladesh 1 Chronic Non-communicable Disease Unit, International Centre for Diarrhoeal Disease Research , Dhaka , Bangladesh 2 Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge , Cambridge , UK 3 Wellcome Trust Sanger Institute , Hinxton, Cambridge , UK 4 Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA , USA During recent decades, Bangladesh has experienced a rapid epidemiological transition from communicable to non-communicable diseases. Coronary heart disease (CHD), with myocardial infarction (MI) as its main manifestation, is a major cause of death in the country. However, there is limited reliable evidence about its determinants in this population. The Bangladesh Risk of Acute Vascular Events (BRAVE) study is an epidemiological bioresource established to examine environmental, genetic, lifestyle and biochemical determinants of CHD among the Bangladeshi population. By early 2015, the ongoing BRAVE John Danesh and Emanuele Di Angelantonio have contributed equally to this work. Non-communicable diseases; Cardiovascular disease; Coronary heart disease; Myocardial infarction; Risk factors; Arsenic; Genetics; Bangladesh; South; Asia; BRAVE - Coronary heart disease (CHD), of which myocardial infarction (MI) is an important manifestation, remains the single leading cause of death worldwide [1]. The majority of premature CHD deaths now occur in low- and middleincome countries [13]. In particular, South Asia has recorded the highest number of life-years lost due to premature CHD, a situation which reflects both the regions large population and the relatively young age at which CHD death occurs in this population [4]. Furthermore, while age-standardised CHD mortality rates have decreased during recent decades in many high-income countries, they have continued to increase in South Asia [5]. Nevertheless, there is limited evidence available about the determinants of CHD in South Asia, even though it could contribute importantly to scientific understanding and to the development of appropriate strategies for the prevention and control of CHD [6]. Bangladesh has experienced steep and sustained increases in the incidence of CHD and other cardiovascular conditions during recent decades [7]. Bangladesh is a country with a population of over 160 million [8], yet it is one of least studied major countries with regard to cardiovascular disease [9]. The burden of CHD in Bangladeshis is not just of local public health concern. For example, CHD mortality has been reported to be more than two times higher among Bangladeshis living in western regions compared to native western populations [10, 11]. The burden of CHD in Bangladeshis living in western regions is also higher than that of most other migrant groups, including South Asians from India and Pakistan [9]. An important challenge is, therefore, to establish informative epidemiological resources in a rigorous yet cost-effective manner to evaluate risk factors among Bangladeshis. The present report provides a description of objectives and methods used in the establishment of the Bangladesh Risk of Acute Vascular Events (BRAVE) study. It also describes the baseline characteristics of the study population recruited so far, and outlines the rationale for the studys further development. The BRAVE study was established in 2011 by the Department of Public Health and Primary Care at the University of Cambridge (the studys international coordinating centre), in collaboration with the Chronic Noncommunicable Disease Unit at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) and the National Institute of Cardiovascular Disease (NICVD) in Bangladesh. The icddr,b is the projects national collaborating centre and houses the local laboratory facilities for the study (Fig. 1). The NICVD, Bangladeshs largest cardiology care centre, treats MI patients from Dhaka (the capital city; population *15 million) as well as from surrounding semiurban and rural areas. BRAVE has received approval from the relevant research ethics committee of each of the institutions involved in participant recruitment. Written informed consent has been obtained from each participant prior to recruitment, including for use of stored samples for biochemical, genetic and other analyses. Data collected in this research are subject to the core data protection principles and requirements of the UK Data Protection Act 1998. The investigators and institutional review boards are committed to ensure that research is conducted according to the latest version of the Declaration of Helsinki, the Universal Declaration on the Human Genome and Human Rights adopted by UNESCO, and other relevant legislation. Study design and participants BRAVE is a retrospective casecontrol study of acute MI (Fig. 2). Following screening by medically-qualified research officers, patients (male or female; aged at least 20 years) admitted to the emergency rooms of the NICVD hospital are eligible for inclusion as MI cases if they fulfil all of the following criteria: (1) presentation at the hospital within 48 h of the onset of sustained clinical symptoms suggestive of MI lasting longer than 20 min; (2) presence of ECG changes indicative of MI (i.e., new pathologic Q waves, at least 1 mm ST elevation in any 2 or more contiguous limb leads or a new left bundle branch block, or new persistent ST-T wave changes diagnostic of a non-Q wave MI); (3) increased cardiac troponin-I (cTnI) levels [12]; (4) no previous cardiovascular disease, defined as self-reported history of angina, MI, coronary revascularisation, transient ischaemic attack, stroke, other cardiovascular disease or evidence of CHD on prior ECG, or in other medical records (eTable 1); and (5) not concurrently hospitalised for any other cardiovascular disease events. Controls were individuals without a previous self-reported history of ca (...truncated)