High-resolution Magnetic Resonance Vessel Wall Imaging of Plaques
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial population
Patients with moderate to severe stenosis (stenosis degree: 50% \~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
605 Participants
are grouped into 1 trial groupGroup A: stroke group
Trial outcomes
Primary outcomes
1
Lumen Stenosis Rate
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%
Time frame
2024.08-2027.122
Identify different plaque components
Time frame
2024.08-2027.12Secondary outcomes
1
Ejection index and maximum wall thickness
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
Time frame
2024.08-2027.122
Wall thickness
maximum wall thickness, minimum wall thickness and average wall thickness
Time frame
2024.08-2027.123
Patch load
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%
Time frame
2024.08-2027.124
Vascular reconstruction index RR
measured by the ratio of the outer wall area of the blood vessel in the lesion to that of the adjacent normal blood vessel
Time frame
2024.08-2027.12Sponsors and contacts
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Source ClinicalTrials.gov
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