Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-24 @ 7:07 AM
Study NCT ID:
NCT03057093
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TIII Over TI in Subjects With Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 903}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial infarction size', 'timeFrame': '5 Days', 'description': 'Assessment of myocardial damage using biomarkers'}], 'secondaryOutcomes': [{'measure': 'Correlation with coronary artery', 'timeFrame': '1 day', 'description': 'Assessment of association of infarct related artery and ECG changes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSTEMI, ECG'], 'conditions': ['NSTEMI - Non-ST Segment Elevation MI']}, 'descriptionModule': {'briefSummary': 'Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at elevated risk.', 'detailedDescription': 'In the present study the investigators assessed the value of T wave changes in subjects with NSTEMI (TIII\\>TI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with acute myocardial infarction without ST segment elevation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NSTEMI and PCI\n\nExclusion Criteria:\n\n* NSTEMI without percutaneous intervention'}, 'identificationModule': {'nctId': 'NCT03057093', 'acronym': 'T-infarction', 'briefTitle': 'TIII Over TI in Subjects With Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Assessment of T Wave Changes of Patients With Acute Non-ST-elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'Twave1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TIII>TI', 'description': 'Subjects with TIII\\>TI in initial ECG', 'interventionNames': ['Other: Non interventional study']}, {'label': 'Non TIII>TI', 'description': 'Subjects without TIII\\>TI in initial ECG', 'interventionNames': ['Other: Non interventional study']}], 'interventions': [{'name': 'Non interventional study', 'type': 'OTHER', 'description': 'retrospective noninterventional study', 'armGroupLabels': ['Non TIII>TI', 'TIII>TI']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the department', 'investigatorFullName': 'Dr. Fikret Er', 'investigatorAffiliation': 'University Hospital Muenster'}}}}