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

Overview

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.

Interventions

• Device 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) .

Primary outcome measures

• Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI. [Time frame: immediately after HR-VWI injection]

Secondary outcome measures (2)

• Comparison of image quality of 5.0T and 3.0T HR-VWI. [Time frame: immediately after HR-VWI injection]
• Comparison of clinicians' visual scale for 5.0T and 3.0T HR-VWI. [Time frame: immediately after HR-VWI injection]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 1 center

• Shanghai Sixth People's Hospital, Shanghai,200023 — Shanghai

Identifiers

NCT: NCT06754956 · Imaging-SISTER study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗