Imaging of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using Different Field Strength MRIs

NCT06754956 | Recruiting DMC

• 1 other identifier: Imaging-SISTER study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Atherosclerotic stenosis of the carotid and intracranial arteries is one of the leading causes of ischemic cerebrovascular events worldwide. Among these, intracranial atherosclerotic stenosis has an incidence rate of up to 46.6% in patients with ischemic stroke or transient ischemic attack (TIA) in China. The continuous advancement of high-resolution vascular wall imaging (HR-VWI) technology has enabled multi-dimensional imaging of the arterial walls of both intracranial and extracranial vessels. By suppressing intravascular flow, this technique allows clear visualization of the vascular wall morphology and signal characteristics, as well as the identification of plaque composition and assessment of vulnerable plaque features. However, due to the smaller size of intracranial atherosclerotic plaques, the image quality and effectiveness of current 3.0T high-resolution magnetic resonance imaging (MRI) are influenced by hardware and software limitations, as well as imaging parameters, making it difficult to accurately perform qualitative and quantitative analysis of intracranial and extracranial plaques. The advent of ultra-high field 5.0T MRI overcomes the limitations of 3.0T MRI in imaging, significantly improving the signal-to-noise ratio and allowing for clearer visualization of the signal characteristics of the arteria.

Conditions

High Resolution Vessel Wall Imaging; Intracranial Atherosclerotic Stenosis, ICAS; Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI.

  immediately after HR-VWI injection

Secondary Outcomes (2)

• Comparison of image quality of 5.0T and 3.0T HR-VWI.

  immediately after HR-VWI injection

• Comparison of clinicians' visual scale for 5.0T and 3.0T HR-VWI.

  immediately after HR-VWI injection

Study Arms (1)

patients underwent both 3.0T and 5.0T HR-VWI MRI

EXPERIMENTAL

Device: The patient will receive two intravenous injections of the same gadoterate meglumine contrast agent.

Interventions

The patient will receive two intravenous injections of the same gadoterate meglumine contrast agent. DEVICE

Each patient will undergo two different field strength HR-VWIs with enhancement, and on each occasion the patient will be injected with contrast DOTAREM (gadoterate meglumine) .

patients underwent both 3.0T and 5.0T HR-VWI MRI

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Moderate to severe intracranial or extracranial arterial stenosis (stenosis degree: 50% to 99%, confirmed by CTA, MRA, or DSA);
• Written informed consent signed by the patient or their legal representative.

You may not qualify if:

• Non-atherosclerotic intracranial arterial stenosis, such as dissection or moyamoya disease;
• Contraindications to MRI, such as claustrophobia or presence of a cardiac pacemaker;
• Allergy to gadolinium-based contrast agents;
• Poor MRI image quality preventing analysis;
• Abnormal liver or kidney function;
• History of any prior endovascular treatment;
• Presence of implants posing potential safety risks in 5.0T MRI, such as non-removable metallic dental prostheses, stents, or other metallic implants.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Sixth People's Hospital, Shanghai,200023

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Splenic Hypoplasia; Arteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yueqi Zhu

CONTACT

+86-21-66301136; zhuyeuqi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): September 23, 2027
• Study Completion (Estimated): December 23, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)