NCT07309718

MPR for Stroke Risk Assessment of ICAS

MRI-Derived Pressure Ratio: a Novel Noninvasive Hemodynamic Biomarker for Stroke Risk Stratification in Intracranial Atherosclerotic Stenosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Intracranial atherosclerotic stenosis (ICAS) carries substantial stroke risk despite optimal medical treatment. Current risk stratification relies primarily on stenosis severity, but novel hemodynamic markers may improve prediction. In this multiple prospective registry study we aim to investigate whether regional hemodynamics, measured by a novel Magnetic resonance imaging-derived Pressure Ratio (MPR) technique, are associated with stroke risk in ICAS.

Detailed description

This study is a multicentre prospective single-arm registry study and the protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. This study is initiated by the investigators, with 5 participating stroke centres , and plans to recruit 400 consecutive patients who meet the inclusion and exclusion criteria. After the enrolment, all participants would be evaluated at baseline, 1 month, 6 months, and 12 months post-enrollment. All participants received standardized medical therapy, including dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines. Multimodal imaging techniques were employed to assess hemodynamic status: luminal stenosis would be evaluated using transcranial Doppler (TCD), computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA), high-resolution MRI and phase-contrast MR angiography (PC-MRA) would be collected to calculate MPR. The primary outcomes were ischemic stroke in the qualifying artery territory or related death within 1 year. There were 5 secondary outcomes, including hemodynamic ischemic stroke in the qualifying artery territory within1 year. An independent Data and Safety Monitoring Board (DSMB) oversees the conduction, safety and efficacy of the study.

Conditions

• ICAS - Intracranial Atherosclerosis
• Stroke Ischemic
• Hemodynamic

Interventions

Type	Name	Description
DRUG	Standardized medical therapy targeting vascular risk factors and stroke prevention	Dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-15
• Completion: 2028-03-31
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China