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

Last updated: January 9, 2025
Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Hypercholesterolemia

Vascular Diseases

Treatment

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

Two gadolinium contrast injections were administered to the patient

Clinical Study ID

NCT06754956
Imaging-SISTER study
  • Ages 18-95
  • All Genders

Study 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

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

Exclusion Criteria:

  • Non-atherosclerotic intracranial arterial stenosis, such as dissection or moyamoyadisease;

  • 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 asnon-removable metallic dental prostheses, stents, or other metallic implants.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: The patient will receive two intravenous injections of the same gadoterate meglumine contrast agent.
Phase:
Study Start date:
January 10, 2025
Estimated Completion Date:
December 23, 2027

Connect with a study center

  • Shanghai Sixth People's Hospital, Shanghai,200023

    Shanghai,
    China

    Active - Recruiting

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