Study of Personalized Prevention Program Effectiveness and Cost in High-Risk Stable Coronary Heart Disease Patients

What this Trial Is About

Researchers are evaluating a personalized prevention program PPP for people with stable coronary heart disease CHD who are at high risk of cardiovascular events. The study includes two parts Part A screens 12,000 stable CHD subjects using biomarkers to identify those at highest risk, while Part B is a randomized clinical trial comparing usual care to the PPP in 2,000 high-risk subjects. The goal is to assess the clinical value and cost-effectiveness of the PPP and validate risk biomarkers for predicting cardiovascular events. Participants in the PPP group will visit the study site six times over three years to receive lifestyle coaching, exercise prescriptions, and medication guidance following European Society of Cardiology guidelines. These activities are supported by digital tools called the CoroPrevention Tool Suite. The usual care group will continue receiving standard care from their physicians and have two study visits during the three years. Participants will undergo evaluations including biomarker measurements, behavioral assessments, questionnaires on nutrition and exercise, and monitoring of cardiovascular events. The study will track outcomes like cardiovascular death, heart attacks, and heart failure over three years. Researchers will also study the impact of behavioral changes, adherence to exercise and medication prescriptions, and the economic value of the prevention program. Safety and progress will be monitored throughout the study period.

Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD