Back to resultsEffect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
Primary Purpose
Coronary Artery Disease, Type II Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Trimetazidine
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, diabetes mellitus
Eligibility Criteria
Inclusion Criteria: coronary artery disease type II diabetes mellitus - Exclusion Criteria: unstable coronary artery syndromes impaired liver and kidney function -
Sites / Locations
Outcomes
Primary Outcome Measures
total ischemic burden
silent ischemia
Secondary Outcome Measures
symptomatic myocardial ischemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00282360
Brief Title
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
Official Title
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Type II Diabetes Mellitus
Keywords
coronary artery disease, diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Trimetazidine
Primary Outcome Measure Information:
Title
total ischemic burden
Title
silent ischemia
Secondary Outcome Measure Information:
Title
symptomatic myocardial ischemia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coronary artery disease type II diabetes mellitus -
Exclusion Criteria:
unstable coronary artery syndromes impaired liver and kidney function
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Marazzi, MD
Organizational Affiliation
H San Raffaele EUR
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
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