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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

561 Participants
are grouped into 1 trial group
Group A: Patients with moderate to severe stenosis (stenosis degree: 70% ~ 99%) in both intracranial and extr

Trial outcomes

Primary outcomes

1

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%

Time frame
2024.8-2027.12
2

Identify different plaque components

Time frame
2024.8-2027.12
3

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.

Time frame
2024.8-2027.12
4

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.

Time frame
2024.8-2027.12

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: