CTRI/2024/02/062577已完成不适用
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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,500
- 试验地点
- 1
- 主要终点
- Mean 10-year ASCVD risk using ASCVD risk estimator plus in study population
研究概览
简要总结
This is a retrospective, observational, cross-sectional, real-world evidence study from Electronic Medical records to assess cardiovascular disease risk in Indian patients. Currently, limited real-world data is available in India on risk levels assessed by ASCVD Estimator Plus. This study aims to assess the ASCVD risk of Individuals from the EMR for whom the data required to assess ASCVD risk is available.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Mean 10-year ASCVD risk using ASCVD risk estimator plus in study population
时间窗: Baseline
次要结局
- Mean lifetime ASCVD risk using ASCVD risk estimator plus in study population(Baseline)
- Mean optimal ASCVD risk using ASCVD risk estimator plus in the study population(Baseline)
- Mean values of TC, LDL-C, HDL-C, SBP, & DBP in the total study population(Baseline)
- Prevalence of comorbidities in the study population(Baseline)
- Prevalence of smoking in the study population(Baseline)
- Drug utilization pattern in the study population(Baseline)
- Correlation of ASCVD Risk with patient’s age & gender, comorbidities, concomitant medications & ASCVD risk factors(Baseline)
研究者
Dr Chintan Khandhedia
Sun Pharma Laboratories Limited
研究点 (1)
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