Classification of Carotid Plaque With Computed Tomography With Fast kVp (Kilovolt Peak)-Switching Technique

Completed

• Conditions: Atherosclerosis; Carotid Stenosis

• Registration Number: NCT02436967
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-29
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-07
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology	4 weeks	The time between radiological examination, surgery and histological analysis is usually approximately 4 weeks

Secondary Outcome Measures

Name	Time	Method
Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI	1 week	The time between fast kVp-switching CT and MRI examinations and reporting is usually approximately 1week.

Trial Locations

Locations (1)

Karolinska Institutet, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden