Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-03 @ 3:44 AM
Study NCT ID:
NCT01850693
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2013-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Coronary Artery Disease in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D020521', 'term': 'Stroke'}], '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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1657}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-08', 'studyFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Repeated stroke', 'timeFrame': 'Participants will be followed until June. 2015, an expeded average of 5 years', 'description': 'newly developed stroke after CCTA scan'}], 'primaryOutcomes': [{'measure': 'MACE (Major Adverse Cardiac Event)', 'timeFrame': 'Participants will be followed until June. 2015, an expeded average of 5 years', 'description': 'MACE was included as follows: 1) all-cause mortality, 2) myocardial infarction, 3) unstable angina requiring hospitalization'}], 'secondaryOutcomes': [{'measure': 'Any cardiac events', 'timeFrame': 'Participants will be followed until June. 2015, an expeded average of 5 years', 'description': '1\\) late revascularization: who underwent revascularization therapy mroe than 90days after CCTA and referral due ot new symptoms or an abnormal function test, 2) heart failure required hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'stroke', 'coronary CT angiography'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary CT angiography.', 'detailedDescription': 'Stroke and coronary artery disease (CAD) share common risk factors and pathological mechanisms. CAD is an important cause of death in patients with stroke.\n\nCurrently, coronary CT angiography (CCTA) is very useful non-invasive tool for detection of CAD and plaque analysis.\n\nTherefore, the investigators aimed to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of CAD in stroke patients through follow-up (more than 5 years) using CCTA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke patients on the basis of TOAST classification', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute stroke patients who diagnosed by clinical and brain MR imaging\n* Who performed coronary CT angiography within 3 months after acute stroke\n\nExclusion Criteria:\n\n* intracranial hemorrhage including intracerebral, subdural or subarachnoid hemorrhage\n* brain tumor\n* Previous myocardial infarction\n* Previously performed percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or other cardiac surgery\n* Insufficient medical record\n* Poor image quality of CCTA scan'}, 'identificationModule': {'nctId': 'NCT01850693', 'acronym': 'ACADIS', 'briefTitle': 'Assessment of Coronary Artery Disease in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Prevalence and Characteristics of Coronary Atherosclerosis in Stroke Patients Using Coronary CT Angiography', 'orgStudyIdInfo': {'id': 'NRF 2010-0023504'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary artery disease, Stroke', 'description': 'Coronary artery disease, stroke, coronary CT angiography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '436-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Eun Ju Chun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiology, Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation of Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}