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Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

This study has been completed.
Information provided by:
IRCCS San Raffaele Identifier:
First received: January 24, 2006
Last updated: NA
Last verified: May 2004
History: No changes posted
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-Blind
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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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

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Please refer to this study by its identifier: NCT00282360

Sponsors and Collaborators
IRCCS San Raffaele
Principal Investigator: Giuseppe Marazzi, MD H San Raffaele EUR
  More Information Identifier: NCT00282360     History of Changes
Other Study ID Numbers: SR05-1-5
Study First Received: January 24, 2006
Last Updated: January 24, 2006

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
Arterial Occlusive Diseases
Vascular Diseases
Vasodilator Agents processed this record on June 23, 2017