Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT00282360
Status:
COMPLETED
Last Update Posted:
2006-01-26
First Post:
2006-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014292', 'term': 'Trimetazidine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-05', 'completionDateStruct': {'date': '2003-10'}, 'lastUpdateSubmitDate': '2006-01-24', 'studyFirstSubmitDate': '2006-01-24', 'studyFirstSubmitQcDate': '2006-01-24', 'lastUpdatePostDateStruct': {'date': '2006-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total ischemic burden'}, {'measure': 'silent ischemia'}], 'secondaryOutcomes': [{'measure': 'symptomatic myocardial ischemia'}]}, 'conditionsModule': {'keywords': ['coronary artery disease', 'diabetes mellitus'], 'conditions': ['Coronary Artery Disease', 'Type II Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nPatients 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ncoronary artery disease type II diabetes mellitus -\n\nExclusion Criteria:\n\nunstable coronary artery syndromes impaired liver and kidney function\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00282360', 'briefTitle': 'Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease', 'orgStudyIdInfo': {'id': 'SR05-1-5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Trimetazidine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giuseppe Marazzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H San Raffaele EUR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}}}}