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

NCT ID: NCT06754956

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2027-12-23

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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) .

Interventions

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

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) .

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yueqi Zhu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Sixth People's Hospital, Shanghai,200023

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yueqi Zhu

Role: CONTACT

zhuyeuqi@hotmail.com

+86-21-66301136

Facility Contacts

Yueqi Zhu, MD

Role: primary

yueqizhu@hotmail.com

+86-21-66301136

Other Identifiers

Imaging-SISTER study

Identifier Type: -

Identifier Source: org_study_id