Trial of Invasive versus Medical therapy of Early coronary artery disease in Diabetes Mellitus

Not Applicable

Completed

• Conditions: Early asymptomatic coronary artery disease in diabetic patients; Circulatory System; Coronary artery disease

• Registration Number: ISRCTN87953632
• Lead Sponsor: niversity Hospital Basel - Department of Cardiology (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-14
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients with diabetes type 2, asymptomatic with respect to angina, no prior coronary artery disease; high risk profile for coronary artery disease (pathologic electrocardiogram [ECG], peripheral vascular disease, microalbuminuria, cardiac autonomic neuropathy, retinopathy, or more than one addititional risk factor for CAD).

Exclusion Criteria

Concomitant disease with prognosis less than 3 years survival. Older than 75 years. End stage renal disease or dialysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac death, myocardial infarction, onset of angina, or hospitalization (for acute coronary syndrom or symptomatic need for revascularization).<br>Myocardial perfusion changes over time: Evolution of ischemic burden and overall abnormality.

Secondary Outcome Measures

Name	Time	Method
Angina class, quality of life, impact of medical therapy.<br>Myocardial perfusion single photon emission computed tomography (SPECT) variables. Left ventricular ejection fraction, volumes.