Clinical Trials Directory

Trials / Completed

CompletedNCT02436967

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
Phase
Study type
Observational
Enrollment
31 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2014-12-01
Primary completion
2021-03-01
Completion
2021-03-01
First posted
2015-05-07
Last updated
2023-10-23

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02436967. Inclusion in this directory is not an endorsement.