MPR for Stroke Risk Assessment of ICAS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke Ischemic; Hemodynamic; ICAS - Intracranial Atherosclerosis
• Intervention / Treatment: Drug: Standardized medical therapy targeting vascular risk factors and stroke prevention

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Jichang Luo, M.D.; Phone Number: +86 13120136577; Email: luojichang_dr@sina.com

Study Locations

• China
  • Xicheng District
    • Beijing, Xicheng District, China, 100053
      • Recruiting
      • Department of Neurosurgery, Xuanwu hospital
      • Contact: Jichang Luo, M.D.; Phone Number: +86 13120136577; Email: luojichang_dr@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with ICAS involving 50% to 99% stenosis of a major intracranial artery in the anterior circulation, including the internal carotid artery (ICA C6-C7 segment) and the middle cerebral artery M1 (MCA-M1) segment.

Description

Inclusion Criteria:

1. Adults aged 18 to 80 years.
2. Intracranial atherosclerotic stenosis ICAS involving a culprit artery in the anterior circulation.
3. Intracranial arterial stenosis of 50% to 99% as measured by the WASID method using TCD, CTA, MRA, or DSA.
4. Written informed consent obtained from the participant or a legal representative.

Exclusion Criteria:

1. Non-atherosclerotic intracranial lesions, including moyamoya disease, vasculitis, vascular dissection, autoimmune diseases, or congenital/genetic abnormalities.
2. More than 50% stenosis of the extracranial carotid artery on the ipsilateral side.
3. Large cerebral infarction involving more than one-half of the territory on DWI imaging, or a baseline modified Rankin Scale score ≥3.
4. Contraindications to antiplatelet therapy or statins.
5. Inability to undergo MRI due to metal implants or claustrophobia.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CASSISS-MPR	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.	the number of participants who suffer from ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year	the number of participants who suffer from transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year after enrollment.	12 months
TIA related to ischemia in the qualifying artery territory within 1 year	the number of participants who suffer from TIA related to ischemia in the qualifying artery territory within 1 year	12 months
any stroke/TIA/ death within 1 year	the number of participants who suffer from any stroke/TIA/ death within 1 year	12 months
hemodynamic ischemic stroke in the qualifying artery territory within 1 year	the number of participants who suffer from hemodynamic ischemic stroke in the qualifying artery territory within 1 year	12 months
embolic stroke within in the qualifying artery territory 1 year	the number of participants who suffer from embolic stroke within in the qualifying artery territory 1 year	12 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Xuanwu Jinan Hospital; Xuanwu Hebei Hospital; Xuanwu Xiongan Hospital; Xuanwu Chifeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Hemodynamic; ICAS - Intracranial Atherosclerosis; Stroke Ischemic; Pressure ratio
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Stroke; Ischemic Stroke; Intracranial Arteriosclerosis
• Other Study ID Numbers: CASSISS-MPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No