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Design and rationale of the North Indian ST-Segment Elevation Myocardial Infarction Registry: A prospective cohort study.

ABSTRACT: ST-segment elevation myocardial infarction (STEMI) is associated with increased mortality and morbidity. Although remarkable progress has been made in the management of STEMI in high-income countries, contemporary data to evaluate processes and outcomes of STEMI care in India is limited. The North Indian ST-segment elevation myocardial infarction (NORIN STEMI) registry is a prospective cohort study based at government funded and largely free of cost tertiary medical centers in New Delhi, India. These hospitals serve a large proportion of the patients with lower socioeconomic status presenting from multiple states in India, as many centers in these states lack adequate specialized cardiovascular care. The study has been approved by the Institutional Review Boards of each institution and informed consent has been obtained from study participants. The NORIN STEMI registry aims to provide important insights regarding contemporary risk factors profiles, practice patterns, and prognosis in patients with STEMI in an underserved population in North India. These findings may identify opportunities to improve the outcomes of patients with STEMI in India.

SUBMITTER: Arora S

PROVIDER: S-EPMC6906983 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Design and rationale of the North Indian ST-Segment Elevation Myocardial Infarction Registry: A prospective cohort study.

Arora Sameer S Qamar Arman A Gupta Puneet P Vaduganathan Muthiah M Chauhan Ishit I Tripathi Ashutosh K AK Sharma Vinamra Y VY Bansal Ankit A Fatima Amber A Jain Gagan G Batra Vishal V Tyagi Sanjay S Khandelwal Lokesh L Kaul Prashant P Rao Sunil V SV Girish Meenahalli Palleda MP Bhatt Deepak L DL Gupta Mohit D MD

Clinical cardiology 20191008 12

ST-segment elevation myocardial infarction (STEMI) is associated with increased mortality and morbidity. Although remarkable progress has been made in the management of STEMI in high-income countries, contemporary data to evaluate processes and outcomes of STEMI care in India is limited. The North Indian ST-segment elevation myocardial infarction (NORIN STEMI) registry is a prospective cohort study based at government funded and largely free of cost tertiary medical centers in New Delhi, India. ...[more]

PMID: 31593344

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Project description:BackgroundOver the past 20 years, the development of regional ST-elevation myocardial infarction (STEMI) care systems has led to remarkable progress in achieving timely coronary reperfusion with attendant improvement in clinical outcomes, including survival. Despite this progress, contemporary STEMI care does not consistently meet the national guideline-recommended goals, which offers an opportunity for further improvement in STEMI outcomes. The lack of single, comprehensive, national STEMI registry complicates our ability to improve STEMI outcomes in particular for high-risk STEMI subsets such as cardiac arrest (CA) and/or cardiogenic shock (CS).ObjectivesTo address this need, the Midwest STEMI Consortium (MSC) was created as a collaboration of 4 large, regional STEMI care systems to provide a comprehensive, multicenter, and prospective STEMI registry without any exclusionary criteria.MethodsThe MSC is a collaboration of 4 large, regional STEMI care systems: Iowa Heart Center in Des Moines, IA; Minneapolis Heart Institute Foundation in Minneapolis, MN; Prairie Heart Institute in Springfield, IL; and The Christ Hospital in Cincinnati, OH. Each has similar standardized STEMI protocol and together include 6 percutaneous coronary intervention (PCI)-capable hospitals and over 100 non-PCI-capable hospitals. Each center had a prospective database that was transferred to a data coordinating center to create the multicenter database. The comprehensive database includes traditional risk factors, cardiovascular history, medications, time to treatment data, detailed angiographic characteristics, and short- and long-term clinical outcomes up to 5-year for myocardial infarction, stroke, and cardiovascular and all-cause mortality. Ten-year mortality rates were assessed by using national death index.ResultsCurrently, the comprehensive database (03/2003-01/2020) includes 14,911 consecutive STEMI patients with mean age of 62.3 ± 13.6 years, female gender (29%), and left anterior descending artery as the culprit vessel (34%). High risk features included: Age >75 years (19%), left ventricular ejection fraction <35% (15%), CA (10%), and CS (8%).ConclusionThis collaboration of 4 large, regional STEMI care systems with broad entry criteria including high-risk STEMI subsets such as CA and/or CS provides a unique platform to conduct clinical research studies to optimize STEMI care.

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) still causes significant mortality and morbidity despite best-practice revascularization and adjunct medical strategies. Within the STEMI population, there is a spectrum of higher and lower risk patients with respect to major adverse cardiovascular and cerebral events (MACCE) or re-hospitalization due to heart failure. Myocardial and systemic metabolic disorders modulate patient risk in STEMI. Systematic cardiocirculatory and metabolic phenotyping to assess the bidirectional interaction of cardiac and systemic metabolism in myocardial ischemia is lacking.MethodsSystemic organ communication in STEMI (SYSTEMI) is an all-comer open-end prospective study in STEMI patients > 18 years of age to assess the interaction of cardiac and systemic metabolism in STEMI by systematically collecting data on a regional and systemic level. Primary endpoint will be myocardial function, left ventricular remodelling, myocardial texture and coronary patency at 6 month after STEMI. Secondary endpoint will be all-cause death, MACCE, and re-hospitalisation due to heart failure or revascularisation assessed 12 month after STEMI. The objective of SYSTEMI is to identify metabolic systemic and myocardial master switches that determine primary and secondary endpoints. In SYSTEMI 150-200 patients are expected to be recruited per year. Patient data will be collected at the index event, within 24 h, 5 days as well as 6 and 12 months after STEMI. Data acquisition will be performed in multilayer approaches. Myocardial function will be assessed by using serial cardiac imaging with cineventriculography, echocardiography and cardiovascular magnetic resonance. Myocardial metabolism will be analysed by multi-nuclei magnetic resonance spectroscopy. Systemic metabolism will be approached by serial liquid biopsies and analysed with respect to glucose and lipid metabolism as well as oxygen transport. In summary, SYSTEMI enables a comprehensive data analysis on the levels of organ structure and function alongside hemodynamic, genomic and transcriptomic information to assess cardiac and systemic metabolism.DiscussionSYSTEMI aims to identify novel metabolic patterns and master-switches in the interaction of cardiac and systemic metabolism to improve diagnostic and therapeutic algorithms in myocardial ischemia for patient-risk assessment and tailored therapy.Trial registrationTrial Registration Number: NCT03539133.

Dataset Information

Design and rationale of the North Indian ST-Segment Elevation Myocardial Infarction Registry: A prospective cohort study.

Publications

Design and rationale of the North Indian ST-Segment Elevation Myocardial Infarction Registry: A prospective cohort study.

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