Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT06110351
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30-days and 6 months', 'description': 'Prevalence of acute mortality'}], 'secondaryOutcomes': [{'measure': 'Acute heart failure', 'timeFrame': '30-days and 6 months', 'description': 'Prevalence of acute heart failure'}, {'measure': 'Arrhythmia', 'timeFrame': '30-days and 6 months', 'description': 'Prevalence of acute arrhythmia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Acute clinical outcomes 1. Mortality 2. Arrhythmia 3. Readmission 4. CVA 5. ADHF'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary PCI STEMI patients having post-PCI biomarkers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-85 years of age\n2. Primary PCI\n3. Post-PCI cardiac biomarker labs'}, 'identificationModule': {'nctId': 'NCT06110351', 'acronym': 'MIRON-ACUTE', 'briefTitle': 'Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction', 'orgStudyIdInfo': {'id': '19978a'}}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Director, Krannert Cardiovascular Research Center', 'investigatorFullName': 'Rohan Dharmakumar', 'investigatorAffiliation': 'Indiana University School of Medicine'}}}}