2023-09-28 14:46:10 +00:00
|
|
|
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'
|
2023-10-01 08:15:07 +00:00
|
|
|
type: article
|
2023-09-28 14:46:10 +00:00
|
|
|
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'
|