Prognosis of Type 2 Diabetic Patients (ARTEMIS)
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.
Cardiovascular Devices Associated With Adverse Incidents, Diagnostic and Monitoring Devices
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prediction of Cardiovascular Events in Type 2 Diabetic Patients With Coronary Artery Disease- Application of Novel Risk Markers and Technology|
- sudden cardiac death [ Time Frame: 2007-2017 (up to ten years) ] [ Designated as safety issue: No ]Death occuurring within one hour after onset of symptoms, or within 24 hours when the patient has last seen alive
- cardiovascular mortality [ Time Frame: 2007-2017 (up to ten years) ] [ Designated as safety issue: No ]Sudden and non-sudden cardiac death, stroke mortality
- non-fatal cardiovascular event [ Time Frame: 2007-2017 (up to ten years) ] [ Designated as safety issue: No ]acute coronary event, myocardial infarction, congestive heart failure, or stroke needing hospitalization
Biospecimen Retention: Samples With DNA
Blood samples are stored for analysis of various biomarkers and for extracting DNAs.
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Specific aims of the study:
- 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.
- 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
- To develop and test the feasibility of home-monitoring of biosignals among the type II diabetic patients with CAD.
- To further explore the molecular, cellular and genetic factors that predispose diabetics to cardiovascular diseases.
- 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
|Contact: Heikki V Huikuri, MD||+ 358 8 firstname.lastname@example.org|
|Contact: Mikko P Tulppo, PhD||+358 email@example.com|
|University of Oulu||Recruiting|
|Oulu, Finland, 90014|
|Contact: Heikki V Huikuri, MD +358 3154108 firstname.lastname@example.org|
|Contact: Mikko P Tulppo, PhD +358405081902 email@example.com|
|Sub-Investigator: Samuli Lepojärvi, MD|
|Sub-Investigator: Mikko P Tulppo, PhD|
|Sub-Investigator: Olli-Pekka Piira, MD|
|Sub-Investigator: Jarkko Niva, MD|
|Sub-Investigator: Jaana Karjalainen, MsC|
|Principal Investigator:||Heikki V Huikuri, MD||University of Oulu|