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Completed

NCT Number: NCT02436967

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotid endarterectomy in clinical healthcare.

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
May 7, 2015
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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