Status:
UNKNOWN
Prognosis of Type 2 Diabetic Patients
Lead Sponsor:
University of Oulu
Collaborating Sponsors:
The Finnish Funding Agency for Technology and Innovation (TEKES)
Conditions:
Cardiovascular Risk Assessment
Eligibility:
All Genders
18-75 years
Brief 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 a...
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 dia...
Eligibility Criteria
Inclusion
- 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:
- sex (1:1)
- age (\<40 years, 40-50 years, 50-60 years, 60-70 years, 70-80 years)
- history of recent (\<3 months) myocardial infarction (1:1)
- 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
- • 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
1880 Patients enrolled
Trial Details
Trial ID
NCT01426685
Start Date
August 1 2007
End Date
June 1 2019
Last Update
April 19 2019
Active Locations (1)
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1
University of Oulu
Oulu, Finland, 90014