Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

Phase 4

Completed

• Conditions: Coronary Artery Disease; Type II Diabetes Mellitus

• Registration Number: NCT00282360
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Patients with coronary artery disease have an abnormal cardiac metabolism. The hypothesis of this study is that shifting cardiac metabolism from free fatty acids to glucose will improve myocardial ischemia

Detailed Description

The present study will evaluate the effect of free fatty acid inhibition with Trimetazidine on silent myocardial ischemia and total ischemic burden in coronary artery disease patients with type II diabetes.

Patients will undergo ambulatory ECG monitoring at baseline and will be randomized to receive on top of thei standard anti-anginal therapy trimetazidine or placebo for 6 months. Patients will repeat the ambulatory ECG monitoring at the end of the study

Study Timeline

• Study Start: 1999-02
• Study Completion: 2003-10
• Status Verified: 2004-05
• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Last Update Submitted: 2006-01-24
• Study First Posted: 2006-01-26
• Last Update Posted: 2006-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

coronary artery disease type II diabetes mellitus -

Exclusion Criteria

unstable coronary artery syndromes impaired liver and kidney function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
total ischemic burden
silent ischemia

Secondary Outcome Measures

Name	Time	Method
symptomatic myocardial ischemia