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NCT Number: NCT07125339

High-resolution Magnetic Resonance Vessel Wall Imaging of Plaques

The primary objective of this study is to investigate the predictive value of High-resolution magnetic resonance vessel wall imaging for future stroke occurrence in patients with moderate to severe intracranial and extracranial artery stenosis.

The secondary objective is to explore the predictive value of baseline high-resolution magnetic resonance vessel wall imaging for plaque progression.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, 20023, China

Location contact

Yue-Qi Zhu, MD

CONTACT

[email protected]

0086-021-64844183

Yue-Qi Zhu, MD

PRINCIPAL_INVESTIGATOR

About this study

Carotid artery origin and intracranial atherosclerotic stenosis (ICAS) are among the leading causes of ischemic cerebrovascular events worldwide, with ICAS accounting for up to 46.6% of ischemic stroke or transient ischemic attacks (TIA) cases in China. Vascular imaging-defined lumen narrowing and clinical manifestations have long been recognized as primary contributors to subsequent ischemic cerebrovascular events. While it is widely accepted that most ischemic events result from ruptured atherosclerotic plaques, hemodynamic disturbances caused by plaque progression within and beyond the cranium, collateral or perforator occlusions, and distal embolism from plaque detachment also play significant roles. Current clinical decision-making relying solely on lumen narrowing dimensions presents substantial limitations. Compared to lumen narrowing alone, detailed characterization of plaque morphology and composition correlates more closely with clinical presentations and subsequent ischemic events.

Advanced high-resolution vessel wall imaging (HR-VWI) technology has achieved 2D and 3D imaging of intracranial and extracranial arterial walls. By suppressing blood flow within the vessels, it can clearly display the morphology and signal characteristics of the vascular walls: Non-invasively describe the detailed structure of atherosclerosis, identifying plaque components, enhancement intensity, reconstruction type, and load, while evaluating the characteristics of vulnerable plaques in extracranial carotid arteries and ICAS, such as intraplaque hemorrhage (IPH), lipid-rich necrotic core (LRNC), and ulcers. Previous studies have shown that these plaque features can provide additional value for distinguishing between stroke cases and asymptomatic patients with narrowed arteries.

However, most of these studies are cross-sectional in nature, and due to limited data, their conclusions vary. Some reports suggest that symptomatic ICAS patients with plaque enhancement may be more related to future ischemic events, while other studies argue that the correlation is minimal. Additionally, previous research investigating the temporal changes in plaque characteristics and their relationship with recurrent stroke has been constrained by small sample sizes (N <15), leading to inconclusive conclusions.

Therefore, more comprehensive studies are needed to evaluate the value of baseline HR-VWI in identifying patients with intracranial and extracranial arterial stenosis at risk of ischemic cerebrovascular events in the future. Through wall plaque imaging studies, it is expected that multi-modal imaging can be used to stratify stroke risk based on cerebral vascular plaques.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years old;
  • Medium or severe stenosis of the internal carotid artery, middle cerebral artery, V4 segment of vertebral artery or basilar artery [stenosis degree: 50% ~ 99%, confirmed by CTA, MRA or DSA];
  • Accept high resolution magnetic resonance angiography; The patient or the legal representative of the patient is able and willing to sign an informed consent form

Exclusion criteria

  • Non-atherosclerotic intracranial and extracranial artery stenosis, such as dissection, smoke disease, etc.;
  • There are contraindications to MRI, such as claustrophobia, metal implants, etc.;
  • Renal insufficiency, elevated serum creatinine (more than twice the upper limit of normal);
  • Patients with severe cardiopulmonary diseases were considered unsuitable for this study;
  • Gadolinium contrast agent allergy;
  • Participants who were unable to complete the study due to mental illness, cognitive or emotional disorder.

Treatment and study plan

Primary outcomes

  1. Lumen Stenosis Rate

    Time frame: 2024.08-2027.12

    The lumen stenosis rate is calculated using the 3D TOF-MRA measurement of the vertebral-basilar artery's narrowest diameter and the normal diameter at the proximal end. The calculation follows the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) standard formula: Lumen Stenosis Rate = [1- (Narrowest Diameter / Normal Diameter at Proximal End)] × 100%

  2. Identify different plaque components

    Time frame: 2024.08-2027.12

Secondary outcomes

  1. Ejection index and maximum wall thickness

    Time frame: 2024.08-2027.12

    Select the narrowest lumen level and manually outline the lumen and wall boundary at the narrowest point. Ejection index = (maximum wall thickness-minimum wall thickness)/ maximum wall thickness

  2. Wall thickness

    Time frame: 2024.08-2027.12

    maximum wall thickness, minimum wall thickness and average wall thickness

  3. Patch load

    Time frame: 2024.08-2027.12

    Select the narrowest lumen level and manually outline the lumen and wall boundaries at the narrowest point. Mainly measure the lumen area (LA), wall area (WA), and normalized wall index (NWI). NWI = WA / (WA + LA) × 100%

  4. Vascular reconstruction index RR

    Time frame: 2024.08-2027.12

    measured by the ratio of the outer wall area of the blood vessel in the lesion to that of the adjacent normal blood vessel

  5. Plaque-to-pituitary stalk contrast enhancement ratio (CR)

    Time frame: 2024.08-2027.12

    CR = (SI plaque post / SI stalk post) × 100%; signal intensity (signal intensity, SI)

Study contacts

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

Yueqi Zhu, MD

CONTACT

[email protected]

0086-21-64844183

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

High-resolution Magnetic Resonance Vessel Wall Imaging of Intracranial and Extracranial Plaques: a Prospective Cohort Registration Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 15, 2025
Registry last updated
Aug 15, 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.

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