Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT04167904
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2018-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'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'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, lithium heparin plasma and EDTA blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4446}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2018-09-03', 'studyFirstSubmitQcDate': '2019-11-15', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute myocardial infarction according to the 4th universal definition of myocardial infarction', 'timeFrame': 'Before discharge from hospital, a median of 2 days', 'description': 'Metric: Yes/No'}], 'secondaryOutcomes': [{'measure': 'Days between hospital discharge and death', 'timeFrame': 'Within 30 days after hospital discharge', 'description': 'Metric: Days. The secondary outcome measures will be combined into a composite endpoint reflecting the time between hospital admission and the first secondary outcome measure'}, {'measure': 'Days between hospital discharge and acute myocardial infarction according to the 4th universal definition of myocardial infarction', 'timeFrame': 'Within 30 days after hospital discharge', 'description': 'Metric: Days.'}, {'measure': 'Days between hospital discharge and coronary revascularization', 'timeFrame': 'Within 30 days after hospital discharge', 'description': 'Metric: Days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Troponin I', 'Myocardial Infarction', 'Sensitivity and Specificity', 'Receiver operation characteristics curve', 'Biomarkers'], 'conditions': ['Myocardial Infarction, Acute']}, 'descriptionModule': {'briefSummary': 'The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. The primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin I in diagnosing acute myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to St. Olavs Hospital (Trondheim University Hospital) with suspected acute myocardial infarction without ST-elevations on ECG (NSTEMI).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalized at St. Olavs hospital\n* blood sampled for troponin analysis due to suspicion of acute myocardial infarction without ST-elevations on ECG less than 4 hours after admitted to the hospital\n\nExclusion Criteria:\n\n* residency outside Norway\n* does not understand Norwegian'}, 'identificationModule': {'nctId': 'NCT04167904', 'acronym': 'BIOMAC', 'briefTitle': 'Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '2018/648'}}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Gustav Mikkelsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}