Cardiovascular Risk Assessment Clinical Trial
Official title:
Prediction of Cardiovascular Events in Type 2 Diabetic Patients With Coronary Artery Disease- Application of Novel Risk Markers and Technology
The study will include 1200 patients with type 2 diabetes and angiographically documented coronary artery disease and 600 matched non-diabetic patients without type 2 diabetes. Extensive traditional and novel risk marker tests are performed for the patients and they will be followed-up for 5 years. Sudden cardiac death is the main outcome measure and various other endpoints are secondary endpoints. As a substudy, 120 diabetic patients and 120 non-diabetic patients will undergo exercise training with home monitoring to assess the effects of exercise training on risk profiles.
Specific aims of the study:
1. To compare several autonomic, electric and metabolic risk markers in a case-control
study between the patients with coronary artery disease with and without type II
diabetes at the time of diagnosis of CAD.
2. To assess the prognostic significance of autonomic markers, electrical markers, coronary
angiographic markers and metabolic markers in predicting the cardiac events among the
CAD patients with and without diabetes
3. To develop and test the feasibility of home-monitoring of biosignals among the type II
diabetic patients with CAD.
4. To further explore the molecular, cellular and genetic factors that predispose diabetics
to cardiovascular diseases.
5. To develop new methods for the early clinical diagnosis of vulnerable subjects
susceptible to the complications of the coronary artery disease in Type 2 diabetes.
5. To assess the effects of controlled exercise training programs to several autonomic,
electrical and metabolic risk markers among the type II diabetic patients with CAD
;