Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT01139632
Status:
UNKNOWN
Last Update Posted:
2011-04-06
First Post:
2010-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-05', 'studyFirstSubmitDate': '2010-06-06', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NAFLD', 'lP-pla2', 'Coronary Arthery Disease'], 'conditions': ['Nonalcoholic Fatty Liver Disease', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.', 'detailedDescription': 'Background: The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of our study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2.\n\nMethods: 60 patients with chest pain and low to intermediate risk for coronary events will undergo Cardiac CT and blood test measurement of enzyme PLA2, markers of inflammation: CRP, MDA(Malondialdehide), Paraoxonase, FFA(Free Fatty Acids), TG(Triglycerids) will performed.\n\nCAD is defined as a stenosis of more than 50% in at least one major coronary artery, unstable plaque defined as low attenuated plaque \\<30HU and fatty liver defined as difference in liver and spleen attenuation value -10HU by using CT.\n\nExpected results : we expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease.\n2. Male and female 18years or older.\n\nIntermediate Risk patients for having significant CAD is defined as:\n\na - chest pain or dyspnea in the presence of negative stress tests; b - the absence of chest pain but positive stress tests; c - the absence of chest pain and of positive stress tests but intermittent arrhythmias.\n\nAge \\<18 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease.\n2. Male and female 18years or older.\n3. Able to provide written informed consent.\n\nIntermediate Risk patients for having significant CAD is defined as:\n\n* chest pain or dyspnea in the presence of negative stress tests;\n* the absence of chest pain but positive stress tests;\n* the absence of chest pain and of positive stress tests but intermittent arrhythmias\n\nExclusion Criteria:\n\n1. Acute coronary syndrome presentation:\n\n * ST segment deviation on ECG and/or\n2. Cardiac troponin elevation.\n3. Chest pain in combination with positive tests for myocardial ischemia\n4. Hemodynamic instability on presentation.\n5. Inability to write inform consent.\n6. Age \\<18 years.\n7. Participation in an investigational study within the previous 30days.'}, 'identificationModule': {'nctId': 'NCT01139632', 'acronym': '0030-10', 'briefTitle': 'The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '0030-10'}}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Safed, Israel', 'country': 'Israel', 'facility': 'Ziv medical center liver unit', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'overallOfficials': [{'name': 'Nimer Assy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZIV MEDICAL CENTER, SAFED ISRAEL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Liver Clinic', 'oldOrganization': 'Ziv medical center'}}}}