Dataset Information

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.

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.

Registration

Trial is registered with Clinical trial registry of India, No: CTRI/2012/09/003002.

SUBMITTER: Alexander T

PROVIDER: S-EPMC3855601 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 T Victor Suma M SM Mullasari Ajit S AS Veerasekar Ganesh G Subramaniam Kala K Nallamothu Brahmajee K BK

BMJ open 20131202 12

<h4>Introduction</h4>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 ...[more]

PMID: 24302505

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Project description:ImportanceChallenges to improving ST-segment elevation myocardial infarction (STEMI) care are formidable in low- to middle-income countries because of several system-level factors.ObjectiveTo examine access to reperfusion and percutaneous coronary intervention (PCI) during STEMI using a hub-and-spoke model.Design, setting, and participantsThis multicenter, prospective, observational study of a quality improvement program studied 2420 patients 20 years or older with symptoms or signs consistent with STEMI at primary care clinics, small hospitals, and PCI hospitals in the southern state of Tamil Nadu in India. Data were collected from the 4 clusters before implementation of the program (preimplementation data). We required a minimum of 12 weeks for the preimplementation data with the period extending from August 7, 2012, through January 5, 2013. The program was then implemented in a sequential manner across the 4 clusters, and data were collected in the same manner (postimplementation data) from June 12, 2013, through June 24, 2014, for a mean 32-week period.ExposuresCreation of an integrated, regional quality improvement program that linked the 35 spoke health care centers to the 4 large PCI hub hospitals and leveraged recent developments in public health insurance schemes, emergency medical services, and health information technology.Main outcomes and measuresPrimary outcomes focused on the proportion of patients undergoing reperfusion, timely reperfusion, and postfibrinolysis angiography and PCI. Secondary outcomes were in-hospital and 1-year mortality.ResultsA total of 2420 patients with STEMI (2034 men [84.0%] and 386 women [16.0%]; mean [SD] age, 54.7 [12.2] years) (898 in the preimplementation phase and 1522 in the postimplementation phase) were enrolled, with 1053 patients (43.5%) from the spoke health care centers. Missing data were common for systolic blood pressure (213 [8.8%]), heart rate (223 [9.2%]), and anterior MI location (279 [11.5%]). Overall reperfusion use and times to reperfusion were similar (795 [88.5%] vs 1372 [90.1%]; P = .21). Coronary angiography (314 [35.0%] vs 925 [60.8%]; P < .001) and PCI (265 [29.5%] vs 707 [46.5%]; P < .001) were more commonly performed during the postimplementation phase. In-hospital mortality was not different (52 [5.8%] vs 85 [5.6%]; P = .83), but 1-year mortality was lower in the postimplementation phase (134 [17.6%] vs 179 [14.2%]; P = .04), and this difference remained consistent after multivariable adjustment (adjusted odds ratio, 0.76; 95% CI, 0.58-0.98; P = .04).Conclusions and relevanceA hub-and-spoke model in South India improved STEMI care through greater use of PCI and may improve 1-year mortality. This model may serve as an example for developing STEMI systems of care in other low- to middle-income countries.

Project description:BackgroundST-segment elevation myocardial infarction (STEMI) is a clinically distinguishable yet lethal sequela of ischaemic heart disease (IHD). In sub-Saharan Africa (SSA), death due to acute STEMI is increasing. In South Africa, there is a paucity of data available on the clinical outcomes of acute STEMI within one year for individuals treated in the public healthcare sector. This study primarily seeks to determine the one-year all-cause mortality rate of acute STEMI. The study also assesses the value of serum cardiac biomarkers of myocardial damage and serum uric acid in predicting all-cause mortality in STEMI.MethodsThis is a single-centre observational prospective cohort of all consecutive individuals presenting with an acute STEMI to the Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) in Johannesburg, South Africa. Research data will be sourced on admission through electronic medical records, blood laboratory results and coronary angiography reports, and at follow-up through periodic telephonic interviews and standardised echocardiograms. At least 355 eligible participants will be continuously followed over one year, and clinical outcomes will be measured 30 days, three months, six months and one year after the index hospitalisation.DiscussionThis study provides insights into the demographic, risk factors and clinical profiles of individuals with STEMI in South Africa. Its findings may improve the risk stratification, prognostication, and therapeutic management of STEMI patients in our setting. By comparing the clinical outcomes between the different coronary reperfusion strategies, our results may guide clinicians in providing better patient treatment, particularly in sub-Saharan Africa, where access to percutaneous coronary intervention may be limited. Furthermore, the study offers insights into the routine use of baseline serum uric acid as a potential low-cost prognostic biomarker of all-cause mortality in STEMI. Finally, this study's findings may be of public health significance to local policymakers to aid in reinforcing primary prevention strategies and developing structured referral networks for timely coronary reperfusion of acute STEMI.

Dataset Information

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

Methods and analysis

Ethics

Dissemination and results

Registration

Publications

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.

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