Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

• Sponsor: IRCCS San Raffaele (Other)
• Overall Status: Completed
• CT.gov ID: NCT00282360
• Collaborator: (none)
• Enrollment: 30
• Duration (Months): 56

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Type II Diabetes Mellitus	Drug: Trimetazidine	Phase 4

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
• Study Start Date: Feb 1, 1999
• Study Completion Date: Oct 1, 2003

Outcome Measures

Primary Outcome Measures

1. total ischemic burden []

2. silent ischemia []

Secondary Outcome Measures

1. symptomatic myocardial ischemia []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

coronary artery disease type II diabetes mellitus -

Exclusion Criteria:

unstable coronary artery syndromes impaired liver and kidney function

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• IRCCS San Raffaele

Investigators

• Principal Investigator: Giuseppe Marazzi, MD, H San Raffaele EUR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00282360
• Other Study ID Numbers: SR05-1-5
• First Posted: Jan 26, 2006
• Last Update Posted: Jan 26, 2006
• Last Verified: May 1, 2004

• Keywords provided by , ,: coronary artery disease; diabetes mellitus
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Trimetazidine

Study Results

No Results Posted as of Jan 26, 2006