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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02436967
Enrollment
31
Registered
2015-05-07
Start date
2014-12-31
Completion date
2021-03-31
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Carotid Stenosis

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.

Interventions

OTHERCarotid 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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology4 weeksThe time between radiological examination, surgery and histological analysis is usually approximately 4 weeks

Secondary

MeasureTime frameDescription
Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI1 weekThe time between fast kVp-switching CT and MRI examinations and reporting is usually approximately 1week.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026