Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06754956

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Sixth People's Hospital, Shanghai,200023

Shanghai, China

Location status: Recruiting

Location contact

Yueqi Zhu, MD

CONTACT

[email protected]

+86-21-66301136

Yueqi Zhu, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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 outcomes

  1. 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 outcomes

  1. Comparison of image quality of 5.0T and 3.0T HR-VWI.

    Time frame: immediately after HR-VWI injection

  2. Comparison of clinicians' visual scale for 5.0T and 3.0T HR-VWI.

    Time frame: immediately after HR-VWI injection

    The clinicians' visual scale is a four-point scale. 1 for inadequate, 2 for adequate, 3 for good, 4 for excellent. In detail, excellent rated images meant clear vessel wall delineation for entire boundary. Good images showed good vessel wall delineation with only small part of obscure/invisible boundary. Adequate rated images stood for reasonable image quality on vessel wall visualization involving some part but less than a quadrant of obscure/invisible boundary. Inadequate images were those in which most of the vessel wall boundaries could not be seen.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 1, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.