Risk stratification of Cardiovascular and other non-communicable diseases such as diabetes mellitus, hypertension and obstructive sleep apnea in apparently healthy individuals using coronary artery disease consumer app
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The primary outcome is to access the validity of the app generated risk score by comparing it with the clinical MESA score for cardiovascular disease risk assessment.
研究概览
简要总结
Background: Cardiovascular diseases (CVD) and other non-communicable diseases (NCDs) such as diabetes, hypertension, and obstructive sleep apnea (OSA) are rising in prevalence, particularly in the Indian population. Early risk identification is crucial but often delayed due to reliance on symptomatic hospital-based assessments. Current risk prediction tools, though widely used, lack validation for the Indian population.
Objective: This cross-sectional study aims to assess the utility of a coronary artery disease consumer mobile application incorporating the BEATS score—a digital biomarker—to stratify CVD and NCD risk in asymptomatic individuals aged 30–60 years. The study further aims to validate the BEATS score against the MESA score and examine correlations with body fat composition and six lifestyle factors.
Methods: A total of 1,000 employees from 10 selected industries/ educational institutions within 20km radius from PSG hospitals will participate. After a 5-day app-based assessment, participants undergo clinical and laboratory evaluations including CT Coronary Calcium Score, body fat composition, blood pressure, glucose levels, lipid profile, and lifestyle assessment. The BEATS score will be compared with clinical outcomes and MESA scores to assess validity.
Expected Outcomes: The study anticipates that the BEATS score will show significant correlation with subclinical atherosclerosis and lifestyle factors, offering a non-invasive, cost-effective alternative for early CVD risk detection. Findings may support large-scale implementation of digital health tools in preventive care.
Significance: This study emphasizes the national importance of digital tools for personalized risk assessment, promoting a culture of preventive healthcare and addressing gaps in early CVD detection in the Indian population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •People aged 30 to 60 years Knows how to operate a smart phone knows to read and understand English Apparently Healthy Individuals of all age groups.
排除标准
- •Known ischemic heart disease patients Cardiomyopathies Congenital anomalies Known case of seriously ill health conditions heart failure, kidney failure, stroke and malignancy.
- •Implanted cardiac devices Psychiatric illness/ psychiatric medications Beta blockers /any medications interfering with heart rate.
结局指标
主要结局
The primary outcome is to access the validity of the app generated risk score by comparing it with the clinical MESA score for cardiovascular disease risk assessment.
时间窗: This is a cross sectional study conducted at a single point in time, with no follow up sessions or observation period
次要结局
- There is no secondary outcome.
- There is no secondary outcome.(NA)
研究者
Dr G Rajendiran
PSG Institute of Medical Sciences & Research