Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT01344694
Status:
UNKNOWN
Last Update Posted:
2011-05-16
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epicardial Fat, Visceral Fat and Coronary Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043497', 'term': '6-pyruvoyltetrahydropterin synthase'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epicardial fat', 'Visceral fat', 'atherosclerosis', 'coronary computed tomography angiography', 'Carotid Doppler ultrasound'], 'conditions': ['Epicardial Fat', 'Visceral Fat', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear.', 'detailedDescription': 'Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear. Aim: Evaluate the link between epicardial fat, visceral fat, liver fat accumulation and cardiovascular diseases and carotis atherosclerosis in patients with the major cardiovascular risk factors and with or without metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '50 patients (age 40-70) with excess of visceral fat (obese), 30 patient with liver fat and 30 sexes, age matched individuals will be recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to cardiac CT will be the source of recruitment.\n* patients with excess of visceral fat,\n* 30 patients with liver fat accumulation\n* 30 sex-age-matched individual (controls) will be enrolled. All patients will undergo a complete family history, personal clinical history, physical examination and blood sampling for biochemical analysis.\n* Informed consent will be obtained from each individual.\n\nExclusion Criteria:\n\n* subjects with severe morbid obesity (body mass index \\[BMI\\] \\> 40),\n* recent history of acute illness,\n* clinical history of ischemic heart disease and cerebrovascular disease,\n* typical chest pain,\n* previous coronary artery disease,\n* conventional coronary angiography, percutaneous interventions, coronary by pass grafting, renal failure, cancer patients,\n* subjects who take drugs that induces hepatic steatosis ( corticosteroids, estrogens, methotrexate, amiodarone and others)'}, 'identificationModule': {'nctId': 'NCT01344694', 'briefTitle': 'Epicardial Fat, Visceral Fat and Coronary Atherosclerosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'Association Between Epicardial Fat, Visceral Fat Accumulation & Cardiovascular Atherosclerosis', 'orgStudyIdInfo': {'id': '0020-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient with liver fat', 'description': '30 patients with liver fat', 'interventionNames': ['Other: patient with liver fat']}, {'label': 'excess of visceral fat', 'description': '50 pts. with excess of visceral fat', 'interventionNames': ['Other: pts. with excess of visceral fat']}, {'label': 'control', 'description': '30 control subjects', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'patient with liver fat', 'type': 'OTHER', 'description': '30 patient with liver fat', 'armGroupLabels': ['patient with liver fat']}, {'name': 'pts. with excess of visceral fat', 'type': 'OTHER', 'description': 'pts. with excess of visceral fat', 'armGroupLabels': ['excess of visceral fat']}, {'name': 'control', 'type': 'OTHER', 'description': '30 control subjects', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'contacts': [{'name': 'Nimer Assy, MD', 'role': 'CONTACT', 'email': 'assy.n@ziv.health.gov.il', 'phone': '972-46828442'}], 'facility': 'Ziv MC', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'centralContacts': [{'name': 'Nimer Assy, MD', 'role': 'CONTACT', 'email': 'assy.n@ziv.health.gov.il', 'phone': '972-46828442'}, {'name': 'Nimer Assy', 'role': 'CONTACT', 'email': 'assy.n@ziv.health.gov.il', 'phone': '972-46828442'}], 'overallOfficials': [{'name': 'Nimer Assy, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziv MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Assy Nimer', 'oldOrganization': 'Ziv Medical center'}}}}