Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Type II Diabetes Mellitus Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

coronary artery disease type II diabetes mellitus -

Exclusion criteria

unstable coronary artery syndromes impaired liver and kidney function

Treatment and study plan

Trimetazidine

Drug

Primary outcomes

total ischemic burden
silent ischemia

Secondary outcomes

symptomatic myocardial ischemia

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start: 1999
Study completion: 2003
First posted: Jan 26, 2006
Registry last updated: Jan 26, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed