MRI-Derived Pressure Ratio: a Novel Noninvasive Hemodynamic Biomarker for Stroke Risk Stratification in Intracranial Atherosclerotic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≥
- •Contraindications to antiplatelet therapy or statins.
- •Inability to undergo MRI due to metal implants or claustrophobia.
研究组 & 干预措施
CASSISS-MPR
干预措施: Standardized medical therapy targeting vascular risk factors and stroke prevention (Drug)
结局指标
主要结局
ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
时间窗: 12 months
the number of participants who suffer from ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
次要结局
- embolic stroke within in the qualifying artery territory 1 year(12 months)
- transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year(12 months)
- any stroke/TIA/ death within 1 year(12 months)
- TIA related to ischemia in the qualifying artery territory within 1 year(12 months)
- hemodynamic ischemic stroke in the qualifying artery territory within 1 year(12 months)