Cardiovascular Risk Assessment Clinical Trial
— ARTEMISOfficial title:
Prediction of Cardiovascular Events in Type 2 Diabetic Patients With Coronary Artery Disease- Application of Novel Risk Markers and Technology
| Verified date | April 2019 |
| Source | University of Oulu |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 1880 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - A total of 1200 patients with CAD and diagnosed type II diabetes and 600 patients with CAD but without evidence of diabetes will be included in the study. The patients will be recruited from the consecutive series of patients undergoing coronary angiography in the division of cardiology of the Oulu University Hospital. First, 600 patients with diabetes will be collected. Thereafter, 600 matched CAD patients without diabetes will be recruited. The groups will be matched in terms of following variables: 1. sex (1:1) 2. age (<40 years, 40-50 years, 50-60 years, 60-70 years, 70-80 years) 3. history of recent (<3 months) myocardial infarction (1:1) 4. type of coronary intervention after angiography (1:1 CABG ). - Diabetes is defined as fasting plasma glucose levels = 7.0 and/or a 2-h postload value in the OGTT 11.1 mmol/l according to definition and diagnosis of diabetes mellitus and intermediate hyperglycemia : report of a WHO/IDF consultation. World Health Organization (WHO) 2006. - - Patients without a diabetes must be normoglycemic defined as plasma glucose levels <6.1 mmol/l in the fasting state and a 2-h postload value < 7.8 mmol/l in the oral glucose tolerance test (OGTT). Exclusion Criteria: - • NYHA class IV despite appropriate treatment of heart failure; - Planned ICD implantation; - Participation in a competing clinical trial that is not accepted by the Steering Committee; - Psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator; - Patient compliance doubtful; - Patients who are geographically or otherwise inaccessible for follow-up; - Pregnancy; - Life expectancy < 1 year; - end-stage renal failure needing dialysis - age < 18 years, or > 80 years - permanent pacemaker or implantable cardioverter-defibrillator |
| Country | Name | City | State |
|---|---|---|---|
| Finland | University of Oulu | Oulu |
| Lead Sponsor | Collaborator |
|---|---|
| University of Oulu | The Finnish Funding Agency for Technology and Innovation (TEKES) |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | sudden cardiac death | Death occuurring within one hour after onset of symptoms, or within 24 hours when the patient has last seen alive | 2007-2017 (up to ten years) | |
| Secondary | cardiovascular mortality | Sudden and non-sudden cardiac death, stroke mortality | 2007-2017 (up to ten years) | |
| Secondary | non-fatal cardiovascular event | acute coronary event, myocardial infarction, congestive heart failure, or stroke needing hospitalization | 2007-2017 (up to ten years) |