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Clinical Trials in China / NCT06754956
Recruiting Not applicable

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

NCT06754956 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Phase
Not applicable
Started
2025-01-10
Last updated
2025-06-29

Condition(s) studied

High Resolution Vessel Wall ImagingIntracranial Atherosclerotic Stenosis, ICASArteriosclerosis

Investigational drug(s) / intervention(s)

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

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) .

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

Sex
ALL
Min age
18 Years
Max age
95 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Sixth People's Hospital, Shanghai,200023 Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06754956 on ClinicalTrials.gov ↗ ← All trials in China