Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT04451967
Status:
UNKNOWN
Last Update Posted:
2020-06-30
First Post:
2020-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Myocardial Infarction Study in Northeastern China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005343', 'term': 'Fibrinolytic Agents'}], 'ancestors': [{'id': 'D050299', 'term': 'Fibrin Modulating Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D006401', 'term': 'Hematologic Agents'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3159}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-09-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause death', 'timeFrame': '2 years post discharge', 'description': 'all-cause death'}], 'secondaryOutcomes': [{'measure': 'major adverse cardiac events (MACE)', 'timeFrame': '2 years post discharge', 'description': 'recurrent angina, non-fatal myocardial infarction, cardiac failure, malignant arrhythmia, and death from cardiovascular causes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '34035090', 'type': 'DERIVED', 'citation': 'Li T, Wu J, Liu J, Sun W, Qi C, Liu B, Wells GA, Wang J; Acute Myocardial Infarction Study in Northeastern China (AMINoC). Protocol for the Acute Myocardial Infarction Study in Northeastern China (AMINoC): a real-world prospective cohort study. BMJ Open. 2021 May 25;11(5):e042936. doi: 10.1136/bmjopen-2020-042936.'}]}, 'descriptionModule': {'briefSummary': 'This is a real-world prospective cohort study aiming to generate knowledge about the characteristics, treatments, and outcomes of hospitalized AMI patients in Jilin Province. The study includes hospitalizations diagnosed of AMI, including ST segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients must be admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, including ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Final inclusion criteria must meet Fourth Universal Definition for Myocardial Infarction (2018)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, meet Fourth Universal Definition for Myocardial Infarction (2018)\n\nExclusion Criteria:\n\n* Types 4a and type 5 AMI'}, 'identificationModule': {'nctId': 'NCT04451967', 'briefTitle': 'Acute Myocardial Infarction Study in Northeastern China', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Jilin University'}, 'officialTitle': 'the Acute Myocardial Infarction Study in Northeastern China', 'orgStudyIdInfo': {'id': 'SecondJilinU-AMINoC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transfer after thrombolysis', 'interventionNames': ['Procedure: thrombolysis']}, {'label': 'Transfer after DAPT'}, {'label': 'Direct transfer'}], 'interventions': [{'name': 'thrombolysis', 'type': 'PROCEDURE', 'otherNames': ['DAPT'], 'description': 'transfer after thrombolysis for STEMI patients within 6h since onset', 'armGroupLabels': ['Transfer after thrombolysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Wang, Doctor', 'role': 'CONTACT', 'email': 'wanghe221@163.com', 'phone': '043188796625'}], 'facility': 'The second hospital of Jilin university', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Tianyi Li, Ph.D', 'role': 'CONTACT', 'email': 'litianyi@jlu.edu.cn', 'phone': '+8615843024731'}], 'overallOfficials': [{'name': 'Bin Liu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Hospital of Jilin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yanbian University Hospital', 'class': 'UNKNOWN'}, {'name': 'Dunhua City Hospital in Jilin Province', 'class': 'UNKNOWN'}, {'name': 'Liaoyuan City Central Hospital', 'class': 'UNKNOWN'}, {'name': "Dongliao People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Songyuan Central Hospital', 'class': 'UNKNOWN'}, {'name': "Changling People's Hospital", 'class': 'UNKNOWN'}, {'name': "Siping Central People's Hospital", 'class': 'OTHER'}, {'name': "The First People's Hospital of Manchu Autonomous County", 'class': 'UNKNOWN'}, {'name': 'Changchun Center Hospital', 'class': 'UNKNOWN'}, {'name': "Nongan People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Beihua University', 'class': 'OTHER'}, {'name': 'Jilin Hospital of Integrated Traditional Chinese and Western Medicine', 'class': 'UNKNOWN'}, {'name': 'Panshi City Hospital', 'class': 'UNKNOWN'}, {'name': 'Tonghua Central Hospital', 'class': 'UNKNOWN'}, {'name': 'Baishan Central Hospital', 'class': 'UNKNOWN'}, {'name': "Jingyu People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Meihekou Central Hospital', 'class': 'UNKNOWN'}, {'name': 'Baicheng Central Hospital', 'class': 'UNKNOWN'}, {'name': 'Tongyu First Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}