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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87953632
Enrollment
400
Registered
2005-09-14
Start date
2004-05-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early asymptomatic coronary artery disease in diabetic patients Circulatory System Coronary artery disease

Interventions

A randomized prospective study of medical therapy versus invasive evaluation of CAD and subsequent revascularization

Sponsors

University Hospital Basel - Department of Cardiology (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Angina class, quality of life, impact of medical therapy. Myocardial perfusion single photon emission computed tomography (SPECT) variables. Left ventricular ejection fraction, volumes.

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026