High-resolution Magnetic Resonance Vessel Wall Imaging of Plaques

NCT07125339 | Not Yet Recruiting DMC

• 1 other identifier: HELP Study
• Study Type: observational
• Target: 605
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate the predictive value of High-resolution magnetic resonance vessel wall imaging for future stroke occurrence in patients with moderate to severe intracranial and extracranial artery stenosis. The secondary objective is to explore the predictive value of baseline high-resolution magnetic resonance vessel wall imaging for plaque progression.

Conditions

Intracranial Atherosclerotic Stenosis

Keywords

high resolution vessel wall imaging

Outcome Measures

Primary Outcomes (2)

• Lumen Stenosis Rate

  The lumen stenosis rate is calculated using the 3D TOF-MRA measurement of the vertebral-basilar artery's narrowest diameter and the normal diameter at the proximal end. The calculation follows the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) standard formula: Lumen Stenosis Rate = \[1- (Narrowest Diameter / Normal Diameter at Proximal End)\] × 100%

  2024.08-2027.12

• Identify different plaque components

  2024.08-2027.12

Secondary Outcomes (5)

• Ejection index and maximum wall thickness

  2024.08-2027.12

• Wall thickness

  2024.08-2027.12

• Patch load

  2024.08-2027.12

• Vascular reconstruction index RR

  2024.08-2027.12

• Plaque-to-pituitary stalk contrast enhancement ratio (CR)

  2024.08-2027.12

Study Arms (1)

stroke group

Patients with moderate to severe stenosis (stenosis degree: 50% \~ 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: 50% \~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study.

You may qualify if:

• At least 18 years old;
• Medium or severe stenosis of the internal carotid artery, middle cerebral artery, V4 segment of vertebral artery or basilar artery \[stenosis degree: 50% \~ 99%, confirmed by CTA, MRA or DSA\];
• Accept high resolution magnetic resonance angiography; 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;
• Gadolinium contrast agent allergy;
• 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 Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, 20023, China

Location

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 15, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)