Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05121818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-11-16
First Post:
2021-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Acute Myocardial Infarction Data Bank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples of patients treated for acute myocardial infarction'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2021-11-03', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Database of patients with acute myocardial infarction', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': "In order to accelerate border crossing between basic research and clinical research in acute myocardial infarction, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic database of acute myocardial infarction, mainly prospective. All data are from patients treated in 5 centers in Shanghai，including Zhongshan Hospital of Fudan University, Shanghai Renji Hospital，Shanghai Tenth People's Hospital，Shanghai First People's Hospital, and Shanghai Tongji Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute myocardial infarction will be enrolled into the study based on the inclusion/exclusion criteria. No randomisation will be performed.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction was diagnosed based on the Fourth Universal Definition of Acute myocardial infarction criteria. The term acute myocardial infarction should be used when there is acute myocardial injury with clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of the following: Symptoms of myocardial ischaemia; New ischaemic ECG changes; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality in a pattern consistent with an ischaemic aetiology; Identification of a coronary thrombus by angiography or autopsy.\n\nExclusion Criteria:\n\n* life expectancy of less than 12 months\n* malignant tumor\n* pregnancy or plans of pregnancy in the one year\n* any anticoagulation therapy such as heparin within 24 hours of baseline blood sampling'}, 'identificationModule': {'nctId': 'NCT05121818', 'briefTitle': 'Prospective Acute Myocardial Infarction Data Bank', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Creation of a Prospective Acute Myocardial Infarction Data Bank', 'orgStudyIdInfo': {'id': 'ZSMI21'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PCI', 'type': 'PROCEDURE', 'description': 'Primary percutaneous coronary intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Shanghai Tongji Hospital, Tongji University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}