Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

This study has been completed.
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00282360
First received: January 24, 2006
Last updated: NA
Last verified: May 2004
History: No changes posted
  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
Endpoint Classification: Efficacy Study
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282360

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

No publications provided

ClinicalTrials.gov Identifier: NCT00282360     History of Changes
Other Study ID Numbers: SR05-1-5
Study First Received: January 24, 2006
Last Updated: January 24, 2006
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 20, 2014