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Abstract
Introduction Atrial fibrillation (AF), the world’s most common arrhythmia, often goes undetected and untreated in low-resource communities, including India, where AF epidemiology is undefined. AF is an important risk factor for stroke, which plagues an estimated 1.6 million Indians annually. As such, early detection of AF and management of high-risk patients is critically important to decrease stroke burden in individuals with AF. This study aims to describe the epidemiology of AF in Anand District, Gujarat, India, characterise the clinical profile of individuals who are diagnosed with AF and determine the performance of two mobile technologies for community-based AF screening.
Methods This observational study builds on findings from a previous feasibility study and leverages two novel technologies as well as an existing community health programme to perform door-to-door AF screening for 2000 people from 60 villages of Anand District, Gujarat, India using local health workers. A single-lead ECG and a pulse-based application is used to screen each individual for AF three times over a period of 5 days. Participants with suspected arrhythmias are followed up by study cardiologist who makes final diagnoses. Participants diagnosed with AF are initiated on treatment based on current anticoagulation guidelines and clinical reasoning.
Analytical plan Age-stratified and sex-stratified prevalence of AF in the Anand District will be calculated for sample and estimated for Anand distribution using survey design weights. Sociodemographic and clinical factors associated with AF will be evaluated using multivariable regression methods. Performance of each mobile technology in detecting AF will be evaluated using a 12-lead ECG interpretation as the gold standard.
Ethics and dissemination This protocol was approved separately by the Institutional Review Board of University of Massachusetts Medical School and the Human Research Ethics Committee at Charutar Arogya Mandal. The findings of this study will be disseminated through peer-reviewed journals and scientific conferences.
- cardiac epidemiology
- valvular heart disease
- public health
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Footnotes
Contributors AS, NF, SR, ST conceptualised, designed and implemented the study in India. AS drafted the initial manuscript and approved the final manuscript as submitted. SK, HP, JB, KT, RS contributed to the design and implementation of the study in India. SK, SR, JB, RS, RG, AGP, JJA, SMN, DDMM contributed to the drafting of the manuscript and approved the final manuscript as submitted. HP, NF, KT contributed to the drafting of the initial manuscript and approved the final manuscript as submitted. AH contributed to the design of the study, drafting and formatting of the manuscript, and approved the final manuscript as submitted. SB contributed to the implementation of the study in India, editing of the manuscript and approved the final manuscript as submitted. RG, AGP conceptualised and designed the study in India. ST provided input to the analyses, contributed to the drafting of the manuscript and approved the final manuscript as submitted. JJA, SMN, DDMM conceptualised and designed the study in India and supported its implementation. KC supported the implementation of the study in India. JJA contributed to the drafting of the manuscript and approved the final manuscript as submitted.
Funding This study is supported by 2016 University of Massachusetts Medical School Office of Global Health Pilot Project Grant. AS received support from the National Center for Advancing Translational Sciences (TL1-TR001454) and JJA received support from the National Institute on Minority Health and Health Disparities (P60-MD006912-05). DDMM’s time was supported by KL2RR031981, 1R15HL121761-01A1, 1UH2TR000921-02 and 1R01HL126911-01A1 from the National Heart, Lung and Blood Institute.
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Competing interests DDMM discloses equity stakes or consulting relationships with Flexcon, Inc., Bristol-Myers Squibb, Inc., Mobile Sense, Inc., ATRIA, Inc. and Boston Biomedical Associates, Inc. He has also received research funding from Sanofi Aventis, Inc., Otsuka Pharmaceuticals, Inc., Philips Healthcare, Inc., Biotronik, Inc. and Pfizer, Inc.
Patient consent Obtained.
Ethics approval UMMS IRB & CAM HREC.
Provenance and peer review Not commissioned; externally peer reviewed.