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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
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...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2013
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3855601/ https://www.ncbi.nlm.nih.gov/pubmed/24302505 http://dx.doi.org/10.1136/bmjopen-2013-003850 |
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author | Alexander, Thomas Victor, Suma M Mullasari, Ajit S Veerasekar, Ganesh Subramaniam, Kala Nallamothu, Brahmajee K |
author_facet | Alexander, Thomas Victor, Suma M Mullasari, Ajit S Veerasekar, Ganesh Subramaniam, Kala Nallamothu, Brahmajee K |
author_sort | Alexander, Thomas |
collection | PubMed |
description | 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. REGISTRATION: Trial is registered with Clinical trial registry of India, No: CTRI/2012/09/003002. |
format | Online Article Text |
id | pubmed-3855601 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-38556012013-12-09 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 Alexander, Thomas Victor, Suma M Mullasari, Ajit S Veerasekar, Ganesh Subramaniam, Kala Nallamothu, Brahmajee K BMJ Open Cardiovascular Medicine 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. REGISTRATION: Trial is registered with Clinical trial registry of India, No: CTRI/2012/09/003002. BMJ Publishing Group 2013-12-02 /pmc/articles/PMC3855601/ /pubmed/24302505 http://dx.doi.org/10.1136/bmjopen-2013-003850 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/ |
spellingShingle | Cardiovascular Medicine Alexander, Thomas Victor, Suma M Mullasari, Ajit S Veerasekar, Ganesh Subramaniam, Kala Nallamothu, Brahmajee K 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Cardiovascular Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3855601/ https://www.ncbi.nlm.nih.gov/pubmed/24302505 http://dx.doi.org/10.1136/bmjopen-2013-003850 |
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