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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426685
|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|