Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT03412435
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2018-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asan Medical Center Myocardial Infarction Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2018-01-21', 'studyFirstSubmitQcDate': '2018-01-21', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A composite event of all-cause death, non-fatal myocardial infarction and repeat revascularization', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'All cause death', 'timeFrame': '5 year'}, {'measure': 'Cardiac death', 'timeFrame': '5 year'}, {'measure': 'Myocardial infarction', 'timeFrame': '5 year'}, {'measure': 'A composite event of all-cause death and myocardial infarction', 'timeFrame': '5 year'}, {'measure': 'A composite event of cardiac death and myocardial infarction', 'timeFrame': '5 year'}, {'measure': 'Repeat revascularization', 'timeFrame': '5 year'}, {'measure': 'Stent thrombosis', 'timeFrame': '5 year', 'description': 'according to Academic Research Consortium (ARC) criteria'}, {'measure': 'Stroke', 'timeFrame': '5 year', 'description': 'A stroke or cerebrovascular accident with loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours after onset or leading to death.'}, {'measure': 'Procedure success', 'timeFrame': '7 days', 'description': 'Successful percutaneous coronary intervention at the intended target lesion with final instant residual stenosis of less than 30% by quantitative coronary angiography (QCA) and no event of death or Q wave myocardial infarction or urgent revascularization during hospitalization.'}, {'measure': 'Surgery success', 'timeFrame': '7 days', 'description': 'Successful surgery defines as no event of death or Q wave myocardial infarction or urgent revascularization during hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute myocardial infarction', 'Myocardial infarction'], 'conditions': ['Myocardial Infarction, Acute', 'Coronary Stenosis']}, 'descriptionModule': {'briefSummary': 'This study evaluates long-term outcome of patients diagnosed as acute myocardial infarction and treated with medication, coronary artery bypass surgery and percutaneous coronary intervention in Asan medical center, Korea.', 'detailedDescription': 'This study will collect 3000 cases retrospectively and 2000 cases prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive acute myocardial infarction patients diagnosed through coronary angiography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive acute myocardial infarction patients diagnosed through coronary angiography'}, 'identificationModule': {'nctId': 'NCT03412435', 'acronym': 'Asan-MI', 'briefTitle': 'Asan Medical Center Myocardial Infarction Registry', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Asan Medical Center Myocardial Infarction Registry', 'orgStudyIdInfo': {'id': 'AMCCV2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myocardial infarction', 'description': 'diagnosed as acute myocardial infarction and treated with medical treatment, coronary artery bypass surgery and percutaneous coronary intervention.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-jung Park, MD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}, {'name': 'Seung-jung Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Seung-jung Park, MD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}, {'name': 'Jung-hee Ham, RN', 'role': 'CONTACT', 'email': 'cvcrc5@amc.seoul.kr', 'phone': '8230104728'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Division of Cardiology', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}