Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT02469051
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2015-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breath-hold Cardiac Hybrid SPECT/CCTA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2015-05-13', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality as visually assessed on a Likert scale', 'timeFrame': '1 day'}, {'measure': 'Number of image artefacts', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referral for cardiac hybrid SPECT/CCTA\n* Male and female subjects 18 years of age or older\n* Written informed consent by the participant after information about the project\n\nExclusion Criteria:\n\n* Contraindications for coronary CT angiography (including renal failure with a GFR \\<30ml/min/1.73m2, allergies to iodinated contrast agents)\n* Pregnancy or breast-feeding\n* Previous coronary revascularisation\n* Inability to follow the examination procedure (e.g. due to language barriers, severe mental disease etc'}, 'identificationModule': {'nctId': 'NCT02469051', 'briefTitle': 'Breath-hold Cardiac Hybrid SPECT/CCTA', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Usefulness of Breath-hold Triggered SPECT-MPI in Cardiac Hybrid SPECT/CCTA Imaging', 'orgStudyIdInfo': {'id': 'USZ-2015-0098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI', 'interventionNames': ['Device: Breathhold SPECT-MPI', 'Device: Standard freebreathing SPECT-MPI', 'Device: Coronary CT angiography']}], 'interventions': [{'name': 'Breathhold SPECT-MPI', 'type': 'DEVICE', 'description': 'Respiratory triggered SPECT myocardial perfusion imaging', 'armGroupLabels': ['Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI']}, {'name': 'Standard freebreathing SPECT-MPI', 'type': 'DEVICE', 'description': 'Clinically indicated, standard non-respiratory triggered SPECT myocardial perfusion imaging', 'armGroupLabels': ['Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI']}, {'name': 'Coronary CT angiography', 'type': 'DEVICE', 'otherNames': ['CCTA'], 'description': 'Clinically indicated coronary CT angiography serving as standard of reference', 'armGroupLabels': ['Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Department of Nuclear Medicine, University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}