Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT00290056
Status:
UNKNOWN
Last Update Posted:
2009-11-04
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillator (ICD) - A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015118', 'term': 'Eicosapentaenoic Acid'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-03', 'studyFirstSubmitDate': '2006-02-09', 'studyFirstSubmitQcDate': '2006-02-09', 'lastUpdatePostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of VT/VF episodes', 'timeFrame': 'continous'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality, cardiac mortality, recurrent and myocardial infarction.', 'timeFrame': 'continous'}, {'measure': 'Atrial arrhythmia and non-sustained ventricular arrhythmia (non-sustained VT or ventricular premature complex (PVC)) as documented by ICD memory or 24 hour ECG (Holter) recording.', 'timeFrame': '24 hours'}, {'measure': 'Whether omega-3 PUFA supplementation exerts different effects according to ischemia severity assessed by stress perfusion nuclear imaging.', 'timeFrame': 'time of the test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CHD', 'Arrhythmia', 'ICD', 'Omega-3 PUFA', 'Nutrition'], 'conditions': ['Coronary Artery Disease', 'Arrhythmia']}, 'descriptionModule': {'briefSummary': 'We hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients.', 'detailedDescription': 'This is a randomized, placebo-controlled, crossover, double- blind interventional study. Patients will receive 3.6 g of EPA and DHA fish oil and placebo oil for 6 months, randomly, in a crossover design, with a four month washout period between treatments.\n\nRandomization will be stratified by ejection fraction (≤ 35% or \\> 35%), and the type of the index arrhythmia (VT - spontaneous or inducible by electrophysiologic study (EPS), versus other - VF, SCD, Primary prevention - MADIT II).\n\nIschemia severity was chosen to be evaluated by Single Photon Emission Computed Tomography (SPECT) during stress (dipyridamol infusion).\n\nSubcutaneous adipose-tissue biopsy, a biomarker considered the gold-standard for the objective assessment of long-term habitual dietary intake of fish and marine omega-3 PUFA (EPA and DHA) will be obtain.\n\nCompliance will be monitored by counting returned capsules or bottles and by measuring the omega-3 PUFA composition in red blood cells (RBC).\n\nThree different types of questionnaires will be used in this trial to obtain more information as to the additional potential benefit of omega-3 PUFA supplementation:\n\n1. The newly Israeli Food Frequency Questionnaire (FFQ) will be used to examine dietary intake of other nutritional habits/patterns and its relationship to the study outcomes.\n2. The Hebrew language SF-36 health survey will be used to examine general health status.\n3. The Back questionnaires will be use to examine possible beneficial effects of fish oil supplementation on depressive symptomatology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* post-MI patients.\n* Both single and Dual chamber ICD recipient.\n* implanted more than 3 months ago.\n* Agree to give written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years of age.\n* ICD implantation as a 'bridge' to heart transplantation.\n* Stable antiarrhythmic medication over the last month prior to enrollment.\n* Patients taking class I antiarrhythmic medication.\n* A projected lifespan less than one year.\n* Participation in another trial (during or within 90 days before the study).\n* Use of supplemental n-3 fatty acids during the last 3 months.\n* Women who are pregnant and of childbearing potential who do not use adequate contraception.\n* Patients known to have a history of recent drug or alcohol abuse. 10) History or current intestinal or hepatic disease."}, 'identificationModule': {'nctId': 'NCT00290056', 'briefTitle': 'Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillator (ICD) - A Randomized Clinical Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'orgStudyIdInfo': {'id': 'SHEBA-04-3494-DL-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Eicosapentanoic acid (EPA) and Docosahexanoic acid (DHA).', 'type': 'DRUG', 'description': '3.6 gram oral supplementation for 6 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239.', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center, Heart Institute, Electrophysiology Unit', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'David Luria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dalit Weisman', 'oldOrganization': 'Sheba Medical Center'}}}}