Tiral of Invasive versus Medical therapy of Early coronary artery disease in Diabetes (TIME-DM) - TIME-DM

• Conditions: The prevalence of type II diabetes is increasing rapidly, contributing importantly to a new epidemic of coronary artery disease (CAD). Atherosclerosis accounts for 65-80% of all death among diabetic patients, a rate 2-to 4-fold higher than in non-diabetics. Furthermore, diabetic patients often have silent CAD .

• Registration Number: EUCTR2006-001430-40-DE
• Lead Sponsor: niversity Hospital Department of Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients qualifying for this study have to be diabetics without history or symptoms of CAD. Furthermore, type II diabetic patients have to be less than 75 years of age and at high risk for CAD defined as additional evidence of cerebral (carotid bruit) or peripheral vascular occlusive artery disease (history of claudication, absent pulse of the dorsalis pedis or posterior tibial artery, or femoral bruit on auscultation), retinopathy, evidence for autonomic dysfunction or increased urinary albumin, proteinuria, or they have to be ?55years old with a history of diabetes II ? 5 years and ?2 risk factors of CAD in addition to diabetes [modified from the American Diabetes Association guidelines, that are based on the clinical judgment of a panel of experts rather than on data])(20).
In addition, informed consent has to be obtained from the patient, before enrollement into the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are: Age above 75 years, severe illness with a life expectancy of less than 3 years and evidence for prior CAD (prior myocardial infarction, angina), and shortness of breath (NYHA IV).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified