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MPR for Stroke Risk Assessment of ICAS

NCT ID: NCT07309718

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-03-31

Brief Summary

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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

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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

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ICAS - Intracranial Atherosclerosis Stroke Ischemic Hemodynamic

Keywords

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ICAS - Intracranial Atherosclerosis Stroke Ischemic Hemodynamic Pressure ratio

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CASSISS-MPR

Standardized medical therapy targeting vascular risk factors and stroke prevention

Intervention Type DRUG

Dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hebei Hospital

UNKNOWN

Sponsor Role collaborator

Xuanwu Xiongan Hospital

UNKNOWN

Sponsor Role collaborator

Xuanwu Chifeng Hospital

UNKNOWN

Sponsor Role collaborator

Xuanwu Jinan Hospital

UNKNOWN

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurosurgery, Xuanwu hospital

Beijing, Xicheng District, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jichang Luo, M.D.

Role: CONTACT

Phone: +86 13120136577

Email: [email protected]

Facility Contacts

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Jichang Luo, M.D.

Role: primary

Other Identifiers

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CASSISS-MPR

Identifier Type: -

Identifier Source: org_study_id