Clinical trial NCT02436967: Classification of Carotid Plaque With Computed Tomography With Fast kVp (Kilovolt Peak)-Switching Technique
Official title: Classification of Carotid Plaque With Computed Tomography With Fast kVp-switching Technique: A Comparison With Histology and 3-Tesla MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Carotid Stenosis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are scheduled for CEA (carotid endarterectomy) and volunteer to participate in this study (fulfilling the incl and excl criteria).

Brief summary: 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.

To compare the ability to detect iodine contrast enhancement in the carotid plaque compared with 3T MRI with gadolinium.

Detailed description: 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.

Approved 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.

Eligibility criteria: Inclusion Criteria:

* 50% stenosis (NASCET) or more based on CTA (CT-angiography),
* MRI or US,
* Scheduled for CEA
* 50 years or older,
* Normal kidney function (estimated GFR (glomerular filtration rate) 60 ml/min or more).

Exclusion Criteria:

* Contraindications to iodine contrast media,
* Contraindications to MRI or gadolinium contrast media.

Primary outcomes:
measure: Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology
timeFrame: 4 weeks
Secondary outcomes:
measure: Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI
timeFrame: 1 week
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Karolinska University Hospital
Study officials:
affiliation: Dept of Clinical Neuroscience, Karolinska Institutet
name: Staffan Holmin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.