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

NCT ID: NCT02436967

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2021-03-31

Brief Summary

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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

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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

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Atherosclerosis Carotid Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Staffan Holmin

Professor in clinical neuroimaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Staffan Holmin, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept of Clinical Neuroscience, Karolinska Institutet

Locations

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Karolinska Institutet, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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 Committee on Vascular Lesions of the Council on Arteriosclerosis, American Heart Association. Circulation. 1995 Sep 1;92(5):1355-74. doi: 10.1161/01.cir.92.5.1355.

Reference Type RESULT
PMID: 7648691 (View on PubMed)

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.f9.

Reference Type RESULT
PMID: 12221054 (View on PubMed)

Other Identifiers

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SN 020 DECTA

Identifier Type: -

Identifier Source: org_study_id

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