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NCT Number: NCT07309718

MPR for Stroke Risk Assessment of ICAS

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery, Xuanwu hospital

Beijing, Xicheng District, 100053, China

Location status: Recruiting

Location contact

Jichang Luo, M.D.

CONTACT

[email protected]

+86 13120136577

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Standardized medical therapy targeting vascular risk factors and stroke prevention

Drug

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

Primary outcomes

  1. ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.

    Time frame: 12 months

    the number of participants who suffer from ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.

Secondary outcomes

  1. transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year

    Time frame: 12 months

    the number of participants who suffer from transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year after enrollment.

  2. TIA related to ischemia in the qualifying artery territory within 1 year

    Time frame: 12 months

    the number of participants who suffer from TIA related to ischemia in the qualifying artery territory within 1 year

  3. any stroke/TIA/ death within 1 year

    Time frame: 12 months

    the number of participants who suffer from any stroke/TIA/ death within 1 year

  4. hemodynamic ischemic stroke in the qualifying artery territory within 1 year

    Time frame: 12 months

    the number of participants who suffer from hemodynamic ischemic stroke in the qualifying artery territory within 1 year

  5. embolic stroke within in the qualifying artery territory 1 year

    Time frame: 12 months

    the number of participants who suffer from embolic stroke within in the qualifying artery territory 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Jichang Luo, M.D.

CONTACT

[email protected]

+86 13120136577

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Xuanwu Chifeng Hospital
  • Xuanwu Hebei Hospital
  • Xuanwu Jinan Hospital
  • Xuanwu Xiongan Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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