Contrast Enhanced SWI for Carotid Plaque Imaging

• Sponsor: Hyun Seok Choi, M.D. (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02749916
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Duration (Months): 40
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Plaque Imaging	Other: Methods of carotid wall imaging

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 25 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Contrast Enhanced Susceptibility Weighted Imaging (SWI) for Characterization of Carotid Plaque
• Study Start Date: Aug 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Detection rate of findings of vulnerable carotid plaque [within 3 days after enrollment]

Secondary Outcome Measures

1. Accuracy in delinating geometry of carotid inner lumen and outer wall [within 3 days after enrollment]

   Diameter of inner lumen and outer wall; Area of inner lumen and outer wall

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of
2	Seoul St. Mary's Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hyun Seok Choi, M.D.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyun Seok Choi, M.D., Associate professor, Seoul St. Mary's Hospital
• ClinicalTrials.gov Identifier: NCT02749916
• Other Study ID Numbers: KC15EIMI0104
• First Posted: Apr 25, 2016
• Last Update Posted: Sep 18, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hyun Seok Choi, M.D., Associate professor, Seoul St. Mary's Hospital: SWI; MP-RAGE; DANTE T1-SPACE

Study Results

No Results Posted as of Sep 18, 2019