Imaging of atherosclerotic plaques in arteries using advanced MRI techniques

Imaging Study of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using 3.0T and 5.0T MRI: A Prospective Self-Controlled Study

This study is testing a new MRI technique to see if it can give better pictures of artery plaques in people with moderate to severe narrowing of the arteries, helping to understand their risk for stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06754956 on ClinicalTrials.gov

What this trial studies

This study aims to improve the imaging of atherosclerotic plaques in both intracranial and extracranial arteries using high-resolution vessel wall imaging (HR-VWI) technology. By utilizing advanced MRI techniques, the study seeks to enhance the visualization of arterial wall morphology and plaque characteristics, which are crucial for assessing the risk of ischemic cerebrovascular events. Participants will receive two intravenous injections of a gadoterate meglumine contrast agent to facilitate this imaging process. The study focuses on patients with moderate to severe arterial stenosis, aiming to provide clearer insights into plaque composition and vulnerability.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with moderate to severe intracranial or extracranial arterial stenosis.

Not a fit: Patients with non-atherosclerotic arterial stenosis or those with contraindications to MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better diagnostic capabilities for assessing stroke risk in patients with atherosclerotic disease.

How similar studies have performed: While the use of high-resolution imaging techniques is advancing, this specific approach to intracranial atherosclerotic plaque imaging is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Shanghai

• Shanghai Sixth People's Hospital, Shanghai,200023 — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yueqi Zhu

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