Contrast Enhanced SWI for Carotid Plaque Imaging

September 17, 2019 updated by: Hyun Seok Choi, M.D.

Contrast Enhanced Susceptibility Weighted Imaging (SWI) for Characterization of Carotid Plaque

This study aims to compare image-based characteristics of carotid walls between symptomatic side and the opposite side. The design of this study is phase IV, prospective observational study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Atherosclerosis of craniocervical arteries are one of most important causes of stroke. Carotid artery is the most frequent site of atherosclerosis. Recent research in carotid artery covers not only morphology of lumen but also direct visualization of carotid plaque or vessel wall. Vulnerable carotid plaques share pathologic features of intra-plaque inflammation and hemorrhage. There have been reports about post-contrast SWI in the field of vascular imaging. We hypothesized SWI is so sensitive to gadolinium based contrast agent and hemorrhage that contrast-enhanced SWI can visualize vulnerable carotid plaque. The purpose of this study is to investigate gadolinium-enhanced SWI in detection of vulnerable carotid plaque and compare it with MP-RAGE and DANTE T1-SPACE. This can be used to guide proper treatment for stroke.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Seoul St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute or recent (within 3months) stroke or TIA (transient ischaemic attack)

Description

Inclusion Criteria:

  • Patients with acute or recent (within 3months) stroke or TIA
  • 50-99% stenosis of internal carotid artery by NASCET criteria
  • Written informed consent, prior to registration

Exclusion Criteria:

  • Hemorrhagic stroke
  • Previous history of carotid endarterectomy (CEA), angioplasty, or stenting
  • Contraindication for MR imaging
  • Hypersensitivity to gadolinium based contrast media
  • Pregnant or lactating women
  • Patients under age of 19-year-old
  • Renal condition : eGFR < 60
  • Patients unable and/or unwilling to comply with treatment or study instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute or recent (within 3months) stroke
Other: Methods of carotid wall imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection rate of findings of vulnerable carotid plaque
Time Frame: within 3 days after enrollment
within 3 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy in delinating geometry of carotid inner lumen and outer wall
Time Frame: within 3 days after enrollment
Diameter of inner lumen and outer wall; Area of inner lumen and outer wall
within 3 days after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyun Seok Choi, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KC15EIMI0104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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