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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Intracranial Atherosclerotic Stenosis, ICAS
High Resolution Vessel Wall Imaging
Arteriosclerosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06754956
Imaging-SISTER study

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

100 participants in 1 patient group

patients underwent both 3.0T and 5.0T HR-VWI MRI
Experimental group
Treatment:
Device: The patient will receive two intravenous injections of the same gadoterate meglumine contrast agent.

Trial contacts and locations

1

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Central trial contact

Yueqi Zhu

Data sourced from clinicaltrials.gov

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