Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-03 @ 8:12 AM
Study NCT ID:
NCT01742156
Status:
TERMINATED
Last Update Posted:
2017-04-07
First Post:
2012-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Blind Randomized Study to Determine the Sensitivity and Specificity of 2 Non-invasive Markers of Early Coronary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'inadequate number of recruita', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of tortuosity of conjunctival vessels', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAD', 'microangiopathy', 'patients', 'more likely', 'to have tortuosity', 'of conjunctival vessels'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Diagonal ear lobe crease and microcirculatory disorder in the conjunctiva are both non invasive methods documented in the literature as early signs of coronary artery disease. We wish to study the sensitivity and specificity of both signs by conducting a single blind study involving patients with documented presence or absence of coronary artery disease via angiogram.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients (CCU) and Outpatients (CHF clinic, congenital heart clinic) who have had an angiogram within the past 12 weeks documenting the extent of coronary artery disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20 to 70 years old\n* angiogram within past 12 weeks\n* stable during post angio period\n* willing to provide informed consent\n\nExclusion Criteria:\n\n* previous eye surgery including cataract surgery\n* previous ophthalmologic disorders\n* previous surgeries involving ears or ear lobes'}, 'identificationModule': {'nctId': 'NCT01742156', 'briefTitle': 'Single Blind Randomized Study to Determine the Sensitivity and Specificity of 2 Non-invasive Markers of Early Coronary Disease', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'orgStudyIdInfo': {'id': 'OPTH-CAD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Presence of coronary disease', 'description': 'All patients with or without coronary disease who are followed in coronary clinics or wards'}, {'label': 'coronary disease', 'description': 'Is coronary disease associated with tortuosity of vessels Patients seen in cardiology clinics'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Nadia Giannetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Cardiology', 'investigatorFullName': 'Nadia Giannetti', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}