Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-04-23 @ 3:50 AM
Study NCT ID:
NCT02436967
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2015-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Classification of Carotid Plaque With Computed Tomography With Fast kVp (Kilovolt Peak)-Switching Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016894', 'term': 'Endarterectomy, Carotid'}], 'ancestors': [{'id': 'D004691', 'term': 'Endarterectomy'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The comparison CT vs histology requires a operated plaque for histology.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2015-03-29', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology', 'timeFrame': '4 weeks', 'description': 'The time between radiological examination, surgery and histological analysis is usually approximately 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI', 'timeFrame': '1 week', 'description': 'The time between fast kVp-switching CT and MRI examinations and reporting is usually approximately 1week.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerosis', 'Carotid Stenosis']}, 'referencesModule': {'references': [{'pmid': '7648691', 'type': 'RESULT', 'citation': 'Stary HC, Chandler AB, Dinsmore RE, Fuster V, Glagov S, Insull W Jr, Rosenfeld ME, Schwartz CJ, Wagner WD, Wissler RW. A definition of advanced types of atherosclerotic lesions and a histological classification of atherosclerosis. A report from the Committee on Vascular Lesions of the Council on Arteriosclerosis, American Heart Association. Circulation. 1995 Sep 1;92(5):1355-74. doi: 10.1161/01.cir.92.5.1355.'}, {'pmid': '12221054', 'type': 'RESULT', 'citation': 'Cai JM, Hatsukami TS, Ferguson MS, Small R, Polissar NL, Yuan C. Classification of human carotid atherosclerotic lesions with in vivo multicontrast magnetic resonance imaging. Circulation. 2002 Sep 10;106(11):1368-73. doi: 10.1161/01.cir.0000028591.44554.f9.'}]}, 'descriptionModule': {'briefSummary': 'Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA classification (American Heart Association)- comparison between histology and CT. The CT is performed with a fast kVp-switching dual energy technique.\n\nTo compare the ability to detect iodine contrast enhancement in the carotid plaque compared with 3T MRI with gadolinium.', 'detailedDescription': 'Patients planned for CEA (carotid endarterectomy) due to carotid stenosis will be examined with one extra CT and MRI before surgery. The CEA specimen is stored in the BiKE-registry (a biobank of operated carotid plaque at the Karolinska Institute). In that registry the patients will be given a personal code which is used to identify the CT, MRI and histology data further on.\n\nApproved by regional ethical review board in Stockholm and local radiation comity at Karolinska University Hospital Solna (Dnr K2435-2014). Informed consent from the participating patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that are scheduled for CEA (carotid endarterectomy) and volunteer to participate in this study (fulfilling the incl and excl criteria).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50% stenosis (NASCET) or more based on CTA (CT-angiography),\n* MRI or US,\n* Scheduled for CEA\n* 50 years or older,\n* Normal kidney function (estimated GFR (glomerular filtration rate) 60 ml/min or more).\n\nExclusion Criteria:\n\n* Contraindications to iodine contrast media,\n* Contraindications to MRI or gadolinium contrast media.'}, 'identificationModule': {'nctId': 'NCT02436967', 'briefTitle': 'Classification of Carotid Plaque With Computed Tomography With Fast kVp (Kilovolt Peak)-Switching Technique', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Classification of Carotid Plaque With Computed Tomography With Fast kVp-switching Technique: A Comparison With Histology and 3-Tesla MRI', 'orgStudyIdInfo': {'id': 'SN 020 DECTA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Carotid endarterectomy in clinical healthcare.', 'type': 'OTHER', 'description': 'For the this study itself there is no intervention caused by the extra CT or MRI. The patients are scheduled for surgery as the routine intervention to reduce the risk of a new stroke in clinical practice. The performed extra diagnostic CT and MRI in this study before surgery will compare the vessel wall images with histology regardless of the patients status or medication.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Staffan Holmin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Clinical Neuroscience, Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in clinical neuroimaging', 'investigatorFullName': 'Staffan Holmin', 'investigatorAffiliation': 'Karolinska Institutet'}}}}