abstract: 'Introduction: Over the past two decades, India has witnessed a

  staggering increase in the incidence and mortality of ST-elevation

  myocardial infarction (STEMI). Indians have higher rates of STEMI and

  younger populations that suffer from it when compared with developed

  countries. Yet, the recommended reperfusion therapy with fibrinolysis

  and percutaneous coronary intervention is available only to a minority

  of patients. This gap in care is a result of financial barriers, limited

  healthcare infrastructure and poor knowledge and accessibility of acute

  medical services for a majority of its population.

  Methods and analysis: This is a prospective, multicentre,

  `pretest/post-test'' quasi-experimental, community-based study. This

  programme will use a `hub-and-spoke'' model of an integrated healthcare

  network based on clusters of primary-care health clinics, small

  hospitals and large tertiary-care facilities. It is an `all-comers''

  study which will enrol consecutive patients presenting with STEMI to the

  participating hospitals. The primary objectives of the study is to

  improve the use of reperfusion therapy and reduce the time from first

  medical contact to device or drug in STEMI patients; and to increase the

  rates of early invasive risk stratification with coronary angiography

  within 3-24 h of fibrinolytic therapy in eligible patients through

  changes in process of care. Outcomes will be measured with statistical

  comparison made before and after implementing the TN-STEMI programme.

  The estimated sample size is based on the Kovai Erode Pilot study, which

  provided an initial work on establishing this type of programme in South

  India. It will be adequately powered at 80\% with a superiority margin

  of 10\% if 36 patients are enrolled per cluster or 108 patients in three

  clusters. Thus, the enrolment period of 9 months will result in a sample

  size of 1500 patients.

  Ethics: This study will be conducted in accordance with the ethical

  principles that have their origin in the current Declaration of Helsinki

  and `ethical guidelines for biomedical research on human participants''

  as laid down by the Indian Council for Medical Research. All

  participating hospitals will still obtain local ethics committee

  approval of the study protocol and written informed consent will be

  obtained from all participants.

  Dissemination and results: Our findings will be reported through

  scientific publications, research conferences and public policy venues

  aimed at state and local governments in India. If successful, this model

  can be extended to other areas of India as well as serve as a model of

  STEMI systems of care for low-income and middle-income countries across

  the world.'
affiliation: 'Alexander, T (Corresponding Author), Kovai Med Ctr \& Hosp, Dept Intervent
  Cardiol, Coimbatore, Tamil Nadu, India.

  Alexander, Thomas, Kovai Med Ctr \& Hosp, Dept Intervent Cardiol, Coimbatore, Tamil
  Nadu, India.

  Victor, Suma M.; Mullasari, Ajit S., Madras Med Mission Hosp, Dept Intervent Cardiol,
  Madras, Tamil Nadu, India.

  Veerasekar, Ganesh, Kovai Med Ctr \& Hosp, Dept Epidemiol, Coimbatore, Tamil Nadu,
  India.

  Subramaniam, Kala, Lotus Clin Res Acad Pvt Ltd, Clin Res, Madras, Tamil Nadu, India.

  Nallamothu, Brahmajee K., Univ Michigan, Ann Arbor, MI 48109 USA.'
article-number: e003850
author: Alexander, Thomas and Victor, Suma M. and Mullasari, Ajit S. and Veerasekar,
  Ganesh and Subramaniam, Kala and Nallamothu, Brahmajee K. and Investigators, TN-STEMI
  Programme
author-email: tomalex41@gmail.com
author_list:
- family: Alexander
  given: Thomas
- family: Victor
  given: Suma M.
- family: Mullasari
  given: Ajit S.
- family: Veerasekar
  given: Ganesh
- family: Subramaniam
  given: Kala
- family: Nallamothu
  given: Brahmajee K.
- family: Investigators
  given: TN-STEMI Programme
da: '2023-09-28'
doi: 10.1136/bmjopen-2013-003850
files: []
issn: 2044-6055
journal: BMJ OPEN
keywords-plus: HEART
language: English
number: '12'
number-of-cited-references: '9'
papis_id: ec821bf07ff47f3e9a08c939faa4681e
ref: Alexander2013protocolprospective
times-cited: '17'
title: 'Protocol for a prospective, controlled study of assertive and timely reperfusion
  for patients with ST-segment elevation myocardial infarction in Tamil Nadu: the
  TN-STEMI programme'
type: Article
unique-id: WOS:000330541400019
usage-count-last-180-days: '0'
usage-count-since-2013: '4'
volume: '3'
web-of-science-categories: Medicine, General \& Internal
year: '2013'