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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02436967
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : March 14, 2018
Information provided by (Responsible Party):
Staffan Holmin, 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.

Condition or disease Intervention/treatment
Atherosclerosis Carotid Stenosis Other: Carotid endarterectomy in clinical healthcare.

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.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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
The comparison CT vs histology requires a operated plaque for histology.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that are scheduled for CEA (carotid endarterectomy) and volunteer to participate in this study (fulfilling the incl and excl criteria).

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02436967

Contact: Staffan Holmin, Professor +46851770000

Karolinska Institutet, Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Staffan Holmin, Professor    +46851770000   
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Staffan Holmin, Professor Dept of Clinical Neuroscience, Karolinska Institutet

Publications of Results:
Responsible Party: Staffan Holmin, Professor in clinical neuroimaging, Karolinska Institutet Identifier: NCT02436967     History of Changes
Other Study ID Numbers: SN 020 DECTA
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Carotid Stenosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases