Multimodal Imaging Evaluation of Vulnerability of Atherosclerotic Plaques: A Comparison of HR-VWI, OCT, and RWS

NCT07133451 | Not Yet Recruiting DMC

• 1 other identifier: Plaque-MAGIC Study
• Study Type: observational
• Target: 561
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the vulnerability of intracranial and extracranial atherosclerotic plaques using HR-VWI, OCT, and RWS technologies, while exploring correlations among these three imaging techniques. Secondary objectives include: 1) Investigating the relationship between RWS and plaque progression and identifying optimal RWS predictors; 2) Further evaluating the clinical value of RWS and HR-VWI in stroke prediction through two-year clinical and HR-VWI follow-up evaluations.

Conditions

Intracranial Atherosclerotic Stenosis

Keywords

high resolution magnetic resonance imaging; intracranial atherosclerotic stenosis; atherosclerotic Plaques; radial Wall Strain; optical Coherence Tomography

Outcome Measures

Primary Outcomes (4)

• Diameter stenosis rate

  According to the 3D TOF-MRA measurement of the lumen diameter at the narrowest part of the intracranial artery and the normal lumen diameter at the proximal end of the stenosis, the stenosis rate was calculated according to the WASID standard: diameter stenosis rate = \[1- (the diameter at the narrowest part / the normal diameter at the proximal end of the stenosis)\] × 100%

  2024.8-2027.12

• Identify different plaque components

  2024.8-2027.12

• OCT scanning scheme and image analysis

  This study utilized the ILUMIEN OPTIS system (Abbott Medical, USA) to obtain frequency-domain OCT (FD-OCT) images. The procedure was performed under general anesthesia. Patients first underwent DSA cerebral angiography, after which a 6F long sheath (Epsylar, Opti Med, USA) was placed proximal to the lesion. A distal access catheter was introduced near the target lesion, and under fluoroscopy guidance, a micro guidewire was advanced through the lesion into the normal arterial lumen distally. The Dragonfly OPTIS imaging catheter (Abbott Medical, USA) was then exchanged for standard "single-track" entry, guiding it into the target vascular lesion. A mixed solution of physiological saline and iohexol contrast agent (GE Healthcare, Cork, Ireland), with a 1:1 concentration, was injected via the distal access catheter. OCT images were captured using automated retraction technology during blood clearance.

  2024.8-2027.12

• RWS

  Using single-position angiographic sequences, the cardiac cycle inference algorithm and automatic frame selection algorithm were applied to identify a key frame and multiple analysis frames with high image quality distributed across different phases of the same cardiac cycle. Subsequently, vascular segments of interest were defined on the key frame, and all corresponding matching segments were obtained through keypoint matching algorithms. The sub-pixel vascular contour segmentation algorithm was then used to generate detailed vessel outlines and calculate radial diameters for all analysis frames. Based on multi-frame vascular contours and diameter data, an automatic 2D point cloud registration algorithm was employed to determine radial alignment relationships between vascular segments. Finally, relative radial deformation was calculated using these alignment relationships and diameter information to derive RWS variation curves.

  2024.8-2027.12

Study Arms (1)

Patients with moderate to severe stenosis (stenosis degree: 70% ~ 99%) in both intracranial and extr

Patients with moderate to severe stenosis (stenosis degree: 70% \~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe stenosis (stenosis degree: 70% \~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study.

You may qualify if:

• At least 18 years old;
• Severe stenosis of intracranial arteries (stenosis degree: 70% \~ 99%, traditional angiography is required to confirm the degree of stenosis according to the criteria of Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study);
• Carry out cerebral angiography and OCT within one week after HR-VWI examination;
• The patient or the legal representative of the patient is able and willing to sign an informed consent form.

You may not qualify if:

• Non-atherosclerotic intracranial and extracranial artery stenosis, such as dissection, smoke disease, etc.;
• There are contraindications to MRI, such as claustrophobia, metal implants, etc.; Renal insufficiency, elevated serum creatinine (more than twice the upper limit of normal);
• Patients with severe cardiopulmonary diseases were considered unsuitable for this study;
• Allergy to iodine or gadolinium contrast agent;
• Participants who were unable to complete the study due to mental illness, cognitive or emotional disorder.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, 200023, China

Location

MeSH Terms

Conditions

Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yueqi Zhu, MD

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueqi Zhu, MD

CONTACT

0086-21-64844183; zhuyueqi@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 21, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1)