Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-29 @ 8:12 PM
Study NCT ID:
NCT01805193
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2013-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Blood Flow by 15O Water PET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial blood flow', 'timeFrame': '1 month', 'description': 'Myocardial blood flow ( ml/g/min) measured by oxygen-15 water positron emission tomography'}], 'secondaryOutcomes': [{'measure': 'Fractional flow reserve', 'timeFrame': '1 month', 'description': 'Fractional flow reserve measured during invasive coronary angiography'}, {'measure': 'Myocardial perfusion', 'timeFrame': '1 month', 'description': 'Myocardial perfusion measured as hypoperfusion on adenosine computed tomography myocardial perfusion imaging'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary heart disease', 'computed tomography myocardial perfusion', 'positron emission tomography', 'oxygen 15 labelled water', 'myocardial perfusion', 'myocardial blood flow'], 'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'Coronary heart disease is a very common condition caused by narrowings in the blood vessel supplying the heart. the investigators are studying new tests to diagnose heart disease. In this study the investigators plan to investigate a special scan called a PET/CT (Positron emission tomography/computed tomography) and a new type of CT (Computed tomography) scan to tell us about the flow of blood to the heart muscle.', 'detailedDescription': 'Participants will undergo PET/CT with oxygen-15 labelled water and computed tomography myocardial perfusion imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients with suspected coronary heart disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected coronary artery disease\n\nExclusion Criteria:\n\n* inability or unwillingness to undergo CT or PET imaging\n* renal failure (serum creatinine \\>200 um/L or eGFR \\<30 ml/min)\n* hepatic failure\n* allergy to iodinated contrast\n* pregnancy\n* contraindication to adenosine\n* inability to give informed consent\n* atrial fibrillation with a fast ventricular rate (\\>70 beats per minute)'}, 'identificationModule': {'nctId': 'NCT01805193', 'briefTitle': 'Myocardial Blood Flow by 15O Water PET', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Validation of Computed Tomography Myocardial Perfusion Imaging Using Quantification of Myocardial Blood Flow by Positron Emission Tomography With 15O-water', 'orgStudyIdInfo': {'id': '12/SS/0078'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected coronary heart disease', 'interventionNames': ['Other: Computed tomography myocardial perfusion imaging', 'Other: Oxygen 15 labelled water positron emission tomography']}], 'interventions': [{'name': 'Computed tomography myocardial perfusion imaging', 'type': 'OTHER', 'armGroupLabels': ['Suspected coronary heart disease']}, {'name': 'Oxygen 15 labelled water positron emission tomography', 'type': 'OTHER', 'armGroupLabels': ['Suspected coronary heart disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Clinical Research Imaging Centre', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'David Newby, PhD DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}