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Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282360
First Posted: January 26, 2006
Last Update Posted: January 26, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
IRCCS San Raffaele
  Purpose
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 Intervention Phase
Coronary Artery Disease Type II Diabetes Mellitus Drug: Trimetazidine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • total ischemic burden
  • silent ischemia

Secondary Outcome Measures:
  • symptomatic myocardial ischemia

Estimated Enrollment: 30
Study Start Date: February 1999
Estimated Study Completion Date: October 2003
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

coronary artery disease type II diabetes mellitus -

Exclusion Criteria:

unstable coronary artery syndromes impaired liver and kidney function

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282360


Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Giuseppe Marazzi, MD H San Raffaele EUR
  More Information

ClinicalTrials.gov Identifier: NCT00282360     History of Changes
Other Study ID Numbers: SR05-1-5
First Submitted: January 24, 2006
First Posted: January 26, 2006
Last Update Posted: January 26, 2006
Last Verified: May 2004

Keywords provided by IRCCS San Raffaele:
coronary artery disease
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Trimetazidine
Vasodilator Agents