[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"st-elevation-stemi-myocardial-infarction-of-anterior-wall\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:st-elevation-stemi-myocardial-infarction-of-anterior-wall":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100580389","impact-cost-and-sustainability-of-a-customized-low-cost-intervention-to-reduce-cardiovascular-disease-burden-in-india-a-cluster-randomized-trial-100580389",false,"NCT06836661","Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial","Effect, Cost, and sustaiNability of a Synergistic, Multipronged, Customized, Low-cost Intervention Package to Reduce cArdiovascular Burden Across India: a cLustEr RCT","ENABLE","Inclusion Criteria:\n\n\\- 1. High-risk primary prevention A. Patients aged more than 40years of any gender without a CVD event (MI, Stroke) with at least two of the following risk factors, A to E with a 10 year documented evidence OF (a to d) a. Diabetes Mellitus b. Hypertension c. Dyslipidaemia d. Microalbuminuria e. Family history of premature CVD event (MI, stroke or CVD-related death under 55 years) B. Patients aged above 50years of any gender without a CVD event (MI, Stroke) with at least one year of documented disease, at least two A to D (Above) 2. High-risk secondary prevention Patients aged above 40 years or above, with a CVD event with any one of the following: options a. MI or stroke less than three months, \\\u003Cbr\u002F\\> b. MI or stroke, more than three months, but less than one year with at least one comorbid condition, that is A to E (Above).\n\nc. Patients aged above 60 years or above with MI or stroke greater than three months BUT less than one year, without any comorbid condition. These patients are expected to have a moderate to high risk of a CVD event or death in the next three years.\n\nExclusion Criteria:\n\n* We will exclude patients with any ONE of the following:\n\n  1. Severe cognitive impairment of any aetiology and have no reliable caregivers.\n  2. Medical conditions with a survival prognosis of less than 12 months.\n  3. Unable to follow-up for the study period","ALL","40 Years","99 Years",{"count":21,"type":22},1560,"ESTIMATED","INTERVENTIONAL",[25],"NA","The ICRAG-2 project aims to assess the impact, cost-effectiveness, and sustainability of a low-cost, multipronged intervention package to reduce cardiovascular disease (CVD) burden in India. Given the high CVD mortality rate in India, this study addresses the urgent need for scalable, evidence-based solutions. The project will unfold in three steps: first, formative research including systematic reviews, cross-sectional studies, and qualitative studies will identify key barriers, facilitators, and refine interventions. Next, a matched-pair cluster randomized controlled trial (CRCT) across 26 clusters will evaluate the intervention's impact on CVD outcomes over three years, focusing on therapeutic lifestyle changes, fixed-dose medications, and task-sharing with non-physician health workers. Finally, the project will engage stakeholders through policy dialogues to support potential national-scale implementation. This trial offers a promising model to reduce CVD incidence through customized, sustainable interventions targeting patients, providers, and the health system.",[28,29],"ST Elevation (STEMI) Myocardial Infarction of Anterior Wall","Cardiovascular Diseases",[31,32,33,34],"CVD","Low cost intervention","task sharing","fixed dose combination pills","NOT_YET_RECRUITING","2025-05-14",{"date":38,"type":39},"2025-05-18","ACTUAL",{"date":41,"type":22},"2025-06-01",{"date":43,"type":22},"2029-06-30",{"name":45,"class":46},"St. John's Research Institute","OTHER"]