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High-resolution Magnetic Resonance Vessel Wall Imaging of Plaques

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07125339
Enrollment
605
Registered
2025-08-15
Start date
2025-08-10
Completion date
2030-06-01
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Atherosclerotic Stenosis

Keywords

high resolution vessel wall imaging

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lumen Stenosis Rate2024.08-2027.12The 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%
Identify different plaque components2024.08-2027.12

Secondary

MeasureTime frameDescription
Patch load2024.08-2027.12Select 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%
Ejection index and maximum wall thickness2024.08-2027.12Select 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
Plaque-to-pituitary stalk contrast enhancement ratio (CR)2024.08-2027.12CR = (SI plaque post / SI stalk post) × 100%; signal intensity (signal intensity, SI)
Vascular reconstruction index RR2024.08-2027.12measured by the ratio of the outer wall area of the blood vessel in the lesion to that of the adjacent normal blood vessel
Wall thickness2024.08-2027.12maximum wall thickness, minimum wall thickness and average wall thickness

Countries

China

Contacts

Primary ContactYueqi Zhu, MD
zhuyueqi@hotmail.com0086-21-64844183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026