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

Atherosclerosis Clinical Trial

Official title:

Classification of Carotid Plaque With Computed Tomography With Fast kVp-switching Technique: A Comparison With Histology and 3-Tesla MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436967
• Other study ID #: SN 020 DECTA
• Status: Completed
• Start date: December 2014
• Est. completion date: March 2021

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Stenosis

Intervention

Other:
• Carotid endarterectomy in clinical healthcare.
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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View 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 Commit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology	The time between radiological examination, surgery and histological analysis is usually approximately 4 weeks	4 weeks
Secondary	Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI	The time between fast kVp-switching CT and MRI examinations and reporting is usually approximately 1week.	1 week