Classification of Carotid Plaque With Computed Tomography With Fast kVp (Kilovolt Peak)-Switching Technique
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|ClinicalTrials.gov Identifier: NCT02436967|
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : March 14, 2018
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.
|Condition or disease||Intervention/treatment|
|Atherosclerosis Carotid Stenosis||Other: Carotid endarterectomy in clinical healthcare.|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Classification of Carotid Plaque With Computed Tomography With Fast kVp-switching Technique: A Comparison With Histology and 3-Tesla MRI|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- 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.
- Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology [ Time Frame: 4 weeks ]The time between radiological examination, surgery and histological analysis is usually approximately 4 weeks
- Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI [ Time Frame: 1 week ]The time between fast kVp-switching CT and MRI examinations and reporting is usually approximately 1week.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436967
|Contact: Staffan Holmin, Professoremail@example.com|
|Karolinska Institutet, Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Staffan Holmin, Professor +46851770000 firstname.lastname@example.org|
|Principal Investigator:||Staffan Holmin, Professor||Dept of Clinical Neuroscience, Karolinska Institutet|