Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-03-05 @ 11:51 PM
Study NCT ID:
NCT05681858
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plaque Burden and Ischemia in MINOCA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000088442', 'term': 'MINOCA'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque burden', 'timeFrame': '1 week'}, {'measure': 'Myocardial ischemia', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MINOCA']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess coronary artery plaque burden, perivascular inflammation and extent of myocardial ischemia in patients presenting with acute myocardial infarction and non-obstructive coronary artery disease. The main question it aims to answer are:\n\n* Identify coronary artery anatomy, plaque burden, composition and high-risk plaque features by CT coronary angiography in MINOCA\n* Assess presence, extent and severity of myocardial ischemia in MINOCA\n\nParticipants will examined by CT coronary angiography and stress \\[12N\\] NH3 PET-MR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized with acute myocardial infarction and non-obstructive coronary artery disease by coronary angiography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute chest pain\n* Elevated troponin\n* Non-obstructive coronary arteries by coronary angiography\n\nExclusion Criteria:\n\n* Obstructive coronary artery disease\n* Contraindications against CT coronary angiography or stress \\[12N\\] NH3 PET-MR\n* Not able to give informed consent'}, 'identificationModule': {'nctId': 'NCT05681858', 'briefTitle': 'Plaque Burden and Ischemia in MINOCA', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Coronary Artery Plaque, Perivascular Inflammation and Myocardial Ischemia in Patients With Myocardial Infraction and Non-obstructive Coronary Arteries', 'orgStudyIdInfo': {'id': '463549'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CT coronary angiography and [12N] NH3 PET-MR', 'description': 'All patients will undergo CT coronary angiography and stress \\[12N\\] NH3 PET-MR', 'interventionNames': ['Diagnostic Test: CT coronary angiography and [12N] NH3 PET-MR']}], 'interventions': [{'name': 'CT coronary angiography and [12N] NH3 PET-MR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Advanced coronary artery plaque analysis, myocardial ischemia and coronary flow reserve', 'armGroupLabels': ['CT coronary angiography and [12N] NH3 PET-MR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Mai Tone Lønnebakken, MD phd', 'role': 'CONTACT', 'email': 'mai.lonnebakken@uib.no', 'phone': '+47 55972220'}, {'name': 'Terje H Larsen, MD phd', 'role': 'CONTACT', 'email': 'terje.hjalmar.larsen@helse-bergen.no', 'phone': '+4755975000'}, {'name': 'Terje H Larsen, MD phd', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Silja Hanseth, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Clinical Science, University of Bergen', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'Haraldsplass Deaconess Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor M.D.', 'investigatorFullName': 'Mai Tone Lønnebakken', 'investigatorAffiliation': 'University of Bergen'}}}}