NCT01426685

Prognosis of Type 2 Diabetic Patients

Prediction of Cardiovascular Events in Type 2 Diabetic Patients With Coronary Artery Disease- Application of Novel Risk Markers and Technology

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,880 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Cardiovascular Risk Assessment

Timeline

• Start date: 2007-08-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2011-08-31
• Last updated: 2019-04-19

Locations

1 site across 1 country: Finland