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A study to assess the cardiovascular disease risk in Indian patients

Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk using ASCVD Risk Estimator Plus in Indian Patients – A Real-world, Retrospective Study from Electronic Medical Records (HEART-STRONG Study) - HEART-STRONG

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/02/062577
Enrollment
4500
Registered
2024-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: NA: NA Control Intervention1: NA: NA

Sponsors

Sun Pharma Laboratories Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex between 20-79 years of age Patients with SBP between 90-200 mmHg Patients with DBP between 60-130 mmHg Patients with TC between 130-320 mgdL Patients with HDL cholesterol between 20-100 mgdL Patients with data on the history of diabetes (Yes No) Patients with data on smoking status (current former never) Patients with data on hypertension treatment (Yes no) Patients with LDL between 30-300 mgdL Patients with data on statin therapy (Yes No) Patients with data on aspirin therapy (Yes No)

Exclusion criteria

Exclusion criteria: Patients with current ASCVD and history of ASCVD (i.e. CHD, such as myocardial infarction, angina, and coronary artery stenosis; Cerebrovascular disease, such as a transient ischemic attack, ischemic stroke, and carotid artery stenosis; Peripheral artery disease, such as claudication; Aortic atherosclerotic disease, such as abdominal aortic aneurysm and descending thoracic aneurysm). Patients with incomplete medical records with respect to the required study parameters

Design outcomes

Primary

MeasureTime frame
Mean 10-year ASCVD risk using ASCVD risk estimator plus in study populationTimepoint: Baseline—

Secondary

MeasureTime frame
Correlation of ASCVD Risk with patient’s age & gender, comorbidities, concomitant medications & ASCVD risk factorsTimepoint: Baseline;Drug utilization pattern in the study populationTimepoint: Baseline;Mean lifetime ASCVD risk using ASCVD risk estimator plus in study populationTimepoint: Baseline;Mean optimal ASCVD risk using ASCVD risk estimator plus in the study populationTimepoint: Baseline;Mean values of TC, LDL-C, HDL-C, SBP, & DBP in the total study populationTimepoint: Baseline;Prevalence of comorbidities in the study populationTimepoint: Baseline;Prevalence of smoking in the study populationTimepoint: Baseline—

Countries

India

Contacts

Public ContactMs Colette Pinto

Sun Pharma Laboratories Limited

Neeraj.Markandeywar@sunpharma.com9022797378

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026