Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
Study NCT ID:
NCT04172168
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2019-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction (LVFR-AMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17568}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-31', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of heart ruputre', 'timeFrame': 'Mortality 30 days', 'description': 'Left Ventricular Free-wall Ruptrue'}], 'secondaryOutcomes': [{'measure': 'Rate of cardiogenic shock', 'timeFrame': 'Hospitalization 30 days', 'description': 'Cardiogenic shock After AMI'}, {'measure': 'Rate of cardiac arrest', 'timeFrame': 'Hospitalization 30 days', 'description': 'Cardiac arrest After AMI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Left Ventricular Free-wall Ruptrue', 'Acute myocardial infarction', 'Coronary angiography'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The Left Ventricular Free-wall Ruptrue (LVFR) is a serious complication caused high mortality.', 'detailedDescription': 'The actual mortality of LVFR is close to 100%. Despite the mortality rate for LVFR has been decreasing with the development of reperfusion therapy, the serious complication remains a difficult challenge. The coronary anatomy distribution associated with LVFR has an interesting phenomenon. From the perspective of different coronary distribution, we can better known the risk factors related to LVFR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population of acute myocardial infarction (STEMI or NSTEMI) patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients be admitted for acute myocardial infarction (STEMI or NSTEMI)\n\nExclusion Criteria:\n\n* Non-cardiovascular comorbidity for AMI'}, 'identificationModule': {'nctId': 'NCT04172168', 'briefTitle': 'Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction (LVFR-AMI)', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen Cardiovascular Hospital, Xiamen University'}, 'officialTitle': 'Clinical Characteristics of Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '9215443689'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart rupture', 'description': 'Include left ventricular free-wall ruptrue after AMI', 'interventionNames': ['Diagnostic Test: Heart rupture']}, {'label': 'Non heart rupture', 'description': 'AMI with non heart rupture'}], 'interventions': [{'name': 'Heart rupture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Left ventricular free-wall ruptrue after AMI', 'armGroupLabels': ['Heart rupture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Wang, Ph.D', 'role': 'CONTACT', 'email': 'mocw361@163.com', 'phone': '+8613400664305'}], 'facility': 'Xiamen Cardiovascular Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Yan Wang, PhD', 'role': 'CONTACT', 'email': 'wy@medmail.com.cn', 'phone': '+8613860488088'}, {'name': 'Bin Wang, PhD', 'role': 'CONTACT', 'email': 'mocw361@163.com', 'phone': '+8613400664305'}], 'overallOfficials': [{'name': 'Yan Wang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiovascular Hospital, Xiamen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen Cardiovascular Hospital, Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Yan Wang', 'investigatorAffiliation': 'Xiamen Cardiovascular Hospital, Xiamen University'}}}}