Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04451551
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2020-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myocardial Perfusion Imaging by 15O-H2O PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2036-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-26', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prognostic value within 10 years', 'timeFrame': '10 years', 'description': 'Number of participants who experience a major adverse cardiac event within 10 years of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Myocardial blood flow', 'timeFrame': '5 Years', 'description': 'The myocardial blood flow of participants assessed by 15O-H2O PET/CT'}, {'measure': 'Coronary flow reserve', 'timeFrame': '5 Years', 'description': 'The coronary flow reserve of participants assessed by 15O-H2O PET/CT'}, {'measure': 'Pulmonary transit time', 'timeFrame': '5 Years', 'description': 'The pulmonary transit time of participants assessed by 15O-H2O PET/CT'}, {'measure': 'Left ventricular end-systolic volume', 'timeFrame': '5 Years', 'description': 'The left ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT'}, {'measure': 'Left ventricular end-diastolic volume', 'timeFrame': '5 Years', 'description': 'The left ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT'}, {'measure': 'Right ventricular end-systolic volume', 'timeFrame': '5 Years', 'description': 'The right ventricular end-systolic volume of participants assessed by 15O-H2O PET/CT'}, {'measure': 'Right ventricular end-diastolic volume', 'timeFrame': '5 Years', 'description': 'The right ventricular end-diastolic volume of participants assessed by 15O-H2O PET/CT'}, {'measure': 'Immediate coronary angiography followup', 'timeFrame': '5 years', 'description': 'Number of participants who undergo coronary angiography within 3 months after primary 15O-H2O PET/CT'}, {'measure': 'Immediate percutaneous coronary intervention (PCI) followup', 'timeFrame': '5 years', 'description': 'Number of participants who undergo percutaneous coronary intervention within 3 months after primary 15O-H2O PET/CT'}, {'measure': 'Immediate coronary artery bypass graft (CABG) followup', 'timeFrame': '5 years', 'description': 'Number of participants who undergo coronary artery bypass graft within 3 months after primary 15O-H2O PET/CT'}, {'measure': 'Prognostic value within 5 years', 'timeFrame': '5 years', 'description': 'Number of participants who experience a major adverse cardiac event within 5 years of follow-up.'}, {'measure': 'Prognostic value within 2 years', 'timeFrame': '2 years', 'description': 'Number of participants who experience a major adverse cardiac event within 2 years of follow-up.'}, {'measure': 'Prognostic value within 1 years', 'timeFrame': '1 years', 'description': 'Number of participants who experience a major adverse cardiac event within 1 years of follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Perfusion Imaging', 'Positron-Emission Tomography', 'Coronary Artery Disease', 'Coronary Flow Reserve', 'Myocardial Blood Flow', 'Prognosis', 'Reference Value'], 'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'The trial will include 5000 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine \\& PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. The patients will undergo the clinical scan as normal.\n\nData from the scans will be used to determine reference values of the examination.\n\nFollow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital, not meeting any exclusion criteria will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known or suspected ischemic heart disease referred for a clinical H2O-PET at Department of Nuclear Medicine and PET Centre, Aarhus University Hospital\n\nExclusion Criteria:\n\n* Claustrophobia, severe asthma, younger than 18 years'}, 'identificationModule': {'nctId': 'NCT04451551', 'briefTitle': 'Myocardial Perfusion Imaging by 15O-H2O PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Myocardial Perfusion Imaging by 15O-H2O PET/CT: Reference Values and Prognostic Value', 'orgStudyIdInfo': {'id': '15O-H2O PET Cohort'}}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Simon Madsen', 'role': 'CONTACT', 'email': 'simmas@rm.dk'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Simon Madsen, MD', 'role': 'CONTACT', 'email': 'simmas@rm.dk', 'phone': '4520140596+'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}