Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-17 @ 11:13 PM
Study NCT ID:
NCT04104269
Status:
UNKNOWN
Last Update Posted:
2019-11-26
First Post:
2019-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Structure Complications After Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006341', 'term': 'Heart Rupture'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35621}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rupture', 'timeFrame': 'Mortality 30 days', 'description': 'Includee free wall ventricular rupture and ventricular septal rupture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart rupture', 'Acute myocardial infarction'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'To determine the incidence and factors associated with heart rupture (HR) in acute myocardial infarction patients.', 'detailedDescription': 'We compared characteristics and angiographic patterns of heart rupture and without heart rupture patients enrolled in the trial.'}, '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\n1\\. Patients be admitted for acute myocardial infarction (STEMI or NSTEMI)\n\nExclusion Criteria:\n\n1\\. Non-cardiovascular comorbidity for AMI'}, 'identificationModule': {'nctId': 'NCT04104269', 'acronym': 'MSC-AMI', 'briefTitle': 'Mechanical Structure Complications After Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen Cardiovascular Hospital, Xiamen University'}, 'officialTitle': 'Comparative Risk Factors of Mechanical Structure Complications After Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '9215443687'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanical Complications', 'description': 'Include free wall ventricular rupture and ventricular septal rupture', 'interventionNames': ['Diagnostic Test: Heart rupture']}, {'label': 'Non-Mechanical Complications', 'description': 'Mechanical complications were not included in patients with AMI'}], 'interventions': [{'name': 'Heart rupture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Free wall rupture and Ventricular septal rupture', 'armGroupLabels': ['Mechanical Complications']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xile Bi, Dr.', 'role': 'CONTACT', 'email': 'bixile@163.com', 'phone': '150930593145'}], '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'}], 'overallOfficials': [{'name': 'Yan Wang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Xiamen Cardiovascular Hospital, Xiamen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen Cardiovascular Hospital, Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph D, FACC', 'investigatorFullName': 'Yan Wang', 'investigatorAffiliation': 'Xiamen Cardiovascular Hospital, Xiamen University'}}}}