Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-24 @ 2:35 PM
Study NCT ID:
NCT03600259
Status:
UNKNOWN
Last Update Posted:
2022-11-02
First Post:
2018-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tianjin Inpatient Acute Myocardial Infarction Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'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': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2018-07-06', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '1 year', 'description': 'Due to recent cardiac causes (eg myocardial infarction, low-volume heart failure, fatal arrhythmias), any deaths from unknown and unexplained deaths and all surgical-related deaths (including treatment-related deaths) will be attributed to cardiac death.Unless there is a clear non-cardiological cause, all deaths are considered heart disease. Specifically, even patients with concurrent potentially fatal non-cardiac diseases (such as cancer, infections) who have any accidental death should be classified as having a heart attack.'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular events', 'timeFrame': '10 days on average (during hospitalization)', 'description': 'Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '1 month', 'description': 'Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '3 months', 'description': 'Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '6 months', 'description': 'Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '1 year', 'description': 'Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Infarction', 'Coronary Disease', 'Coronary Artery Disease', 'Myocardial Ischemia'], 'conditions': ['Myocardial Infarction, Acute']}, 'referencesModule': {'references': [{'pmid': '32149760', 'type': 'DERIVED', 'citation': 'Gao MD, Zhang EY, Liu YY, Li XW, Xiao JY, Sun GY, Liu Y. Intracoronary pressure gradient measurement in acute myocardial infarction patients with the no-reflow phenomenon during primary percutaneous coronary intervention. Chin Med J (Engl). 2020 Apr 5;133(7):766-772. doi: 10.1097/CM9.0000000000000709.'}]}, 'descriptionModule': {'briefSummary': 'Acute myocardial infarction(AMI) is the most serious manifestation of coronary artery disease. AMI is characterized by high mortality, high disability, and high cost. However, multicenter research on AMI with large sample size in Tianjin or even China is limited. By including AMI in 36 hospitals,this multicenter study will capture the changes in epidemiological trends ,analyze the status of treatment in Tianjin, and explore the best treatment strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients with acute myocardial infarction from 36 hospitals in Tianjin were enrolled between January 2015 and January 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients with acute myocardial infarction according to Cardiac biomarker values \\[Selective cardiac troponin (cTc) elevation and/or decline detection, at least one value exceeds the 99% reference limit (URL) and at least one of the following:（1）Symptoms of myocardial ischemia；（2）New or suspected new obvious ST-T changes or new left bundle branch block (LBBB)；（3）ECG pathological Q waves；（4）Image evidence of recent loss of viable myocardium, or new regional wall motion abnormalities；（5）Coronary thrombosis confirmed by angiography or autopsy.\\]\n\nExclusion Criteria:\n\n* Those who did not meet the diagnosis of acute myocardial infarction (no myocardial ischemia-related symptoms, elevation of markers of myocardial necrosis and imaging findings of myocardial infarction); those who met the inclusion criteria but refused to participate in the study; The researchers judged that the subjects had poor compliance and could not Complete follow-up as required.'}, 'identificationModule': {'nctId': 'NCT03600259', 'acronym': 'TAMI', 'briefTitle': 'Tianjin Inpatient Acute Myocardial Infarction Registry', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Chest Hospital'}, 'officialTitle': 'Cohort Study of Acute Myocardial Infarction in Tianjin', 'orgStudyIdInfo': {'id': 'TAMI20180705'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Myocardial Infarction'}]}, 'contactsLocationsModule': {'locations': [{'zip': '300051', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yin Liu, M.D.', 'role': 'CONTACT', 'email': 'tami2018@163.com', 'phone': '+86-13502152283'}], 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Yin Liu, M.D', 'role': 'CONTACT', 'email': 'tami2018@163.com', 'phone': '+86-13502152283'}, {'name': 'Jixiang Wang, PHD', 'role': 'CONTACT', 'email': 'tami2018@163.com', 'phone': '+86-13752068790'}], 'overallOfficials': [{'name': 'Yin Liu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Cardiology Department, Tianjin Chest Hospital', 'investigatorFullName': 'Yin Liu,MD', 'investigatorAffiliation': 'Tianjin Chest Hospital'}}}}