Clinical trial NCT06754956: Imaging of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using Different Field Strength MRIs
Official title: Imaging Study of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using 3.0T and 5.0T MRI: a Prospective Self-Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Resolution Vessel Wall Imaging
Intracranial Atherosclerotic Stenosis, ICAS
Arteriosclerosis
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI.
timeFrame: immediately after HR-VWI injection
Secondary outcomes:
measure: Comparison of image quality of 5.0T and 3.0T HR-VWI.
timeFrame: immediately after HR-VWI injection
measure: Comparison of clinicians' visual scale for 5.0T and 3.0T HR-VWI.
timeFrame: immediately after HR-VWI injection
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital, Shanghai,200023
Study officials:
References: