Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT05551351
Status:
TERMINATED
Last Update Posted:
2025-04-16
First Post:
2022-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CT in Calcified Coronary Arteries With Photon Counting Detector
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Enrollment rate too slow to reach anticipated number of participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-19', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of CT concerning coronary stenosis with conventional angiography as reference', 'timeFrame': '1 day. (Coronary angiography is usually performed the same day as cardiac CT.)', 'description': 'Coronary angiography with or without FFR is performed as part of routine care for included patients. The outcome measure is the agreement between coronary CT and coronary angiography.'}], 'secondaryOutcomes': [{'measure': 'Image quality', 'timeFrame': '1 day. (Image quality is assessed on the performed examination)', 'description': 'Image quality on CT examination according to European guidelines on quality criteria for computed tomography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Computed Tomography', 'Photon Counting Detector'], 'conditions': ['Coronary Stenosis', 'Calcific Coronary Arteriosclerosis']}, 'descriptionModule': {'briefSummary': 'Coronary CT angiography is challenging in patients with more than mildly calcified coronary vessels, because of calcium artefacts that prevents evaluation of the lumen. The purpose of the CCT-PCD-1-study is to evaluate the diagnostic accuracy and image quality in coronary CT angiography using a commercially available CT system equipped with a photon counting detector technology.\n\nPatients referred for cardiac CT and conventional coronary angiography as part of routine preoperative evaluation before Transcatheter Aortic Valve Implantation (TAVI) will be asked for inclusion in the study. This group of patients has generally a coronary artery calcium burden and perform cardiac CT and coronary angiography as part of routine care.\n\nThe diagnostic accuracy concerning significant coronary artery stenosis on the preoperative CT will be evaluated with the conventional coronary angiography as reference. Also, CT examination image quality will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population are at least 65 years old with an expected median age of \\~80 years. This group of patients has generally a high coronary artery calcium burden which prevents conventional cardiac CT from evaluation of the coronary arteries.\n\nSince cardiac CT and coronary artery angiography is performed as part of routine care in this patient cohort, no extra examinations are needed for the reference measure of the primary outcome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred for cardiac CT AND conventional coronary angiography as part of routine preoperative evaluation.\n\nExclusion Criteria:\n\n* \\<65 years old.\n* Heart arrhythmia.\n* Heart rate \\>90/min with contraindication against beta blockers.\n* Not capable of giving informed consent\n* eGFR \\<30 mL/min/1.73m2'}, 'identificationModule': {'nctId': 'NCT05551351', 'acronym': 'CCT-PCD-1', 'briefTitle': 'CT in Calcified Coronary Arteries With Photon Counting Detector', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': 'CT av förkalkade kranskärl Med fotonräknarteknik', 'orgStudyIdInfo': {'id': '278326'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary CT', 'description': 'The single cohort consists of all patients enrolled in the study. All participants performs cardiac CT and coronary angiography as part of routine care.', 'interventionNames': ['Diagnostic Test: Cardiac CT with photon counting detector']}], 'interventions': [{'name': 'Cardiac CT with photon counting detector', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cardiac CT including the coronary arteries. The cardiac CT is performed in routine care for the included patients.', 'armGroupLabels': ['Coronary CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Örebro', 'country': 'Sweden', 'facility': 'Röntgenkliniken Universitetssjukhuset Örebro', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Mats Lidén, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Örebro University, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Örebro County', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}