Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 2:14 PM
Study NCT ID:
NCT01158066
Status:
UNKNOWN
Last Update Posted:
2011-04-06
First Post:
2010-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-05', 'studyFirstSubmitDate': '2010-07-04', 'studyFirstSubmitQcDate': '2010-07-07', 'lastUpdatePostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total calcium score measurement', 'timeFrame': '1 month', 'description': 'total calcium score will be measured'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NAFLD', 'Calcium score', 'Liver Fat', 'Visceral fat', 'excessive visceral fat', 'excessive liver fat accumulation', 'Biomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)'], 'conditions': ['Coronary Artery Calcification']}, 'descriptionModule': {'briefSummary': 'Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial', 'detailedDescription': 'Coronary artery disease are 8 times more prevalent in patients with NAFLD that the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial. AIM: the aim is to evaluate the association between CAC score ( CT) and NAFLD (CT). the working hypothesis is that Beside the traditional risk factors including age, diabetes, NAFLD is also associated with moderate to high risk of CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo cardiac CT for patients with low to intermediate risk for CAD\n\nExclusion Criteria:\n\n* Patients with PCI or CABG will be excluded'}, 'identificationModule': {'nctId': 'NCT01158066', 'briefTitle': 'Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'Association Between NAFLD and Coronary Artery Calcification', 'orgStudyIdInfo': {'id': 'NAFLD and CAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CT cardiac', 'description': 'the patient will undergo cardiac CT', 'interventionNames': ['Procedure: CT Cardiac']}], 'interventions': [{'name': 'CT Cardiac', 'type': 'PROCEDURE', 'description': 'the patient will undergo cardiac CT', 'armGroupLabels': ['CT cardiac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Safed, Israel', 'country': 'Israel', 'contacts': [{'name': 'Nimer Assy, MD', 'role': 'CONTACT', 'email': 'assy.n@ziv.health.gov.il', 'phone': '+972-46828445'}], 'facility': 'Ziv medical center liver unit', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'centralContacts': [{'name': 'Assy Nimer, MD', 'role': 'CONTACT', 'email': 'assy.n@ziv.health.gov.il', 'phone': '+97246828445'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Liver Clinic', 'oldOrganization': 'Ziv medical center'}}}}