Department of Neurosurgery, Xuanwu hospital
Beijing, Xicheng District, 100053, China
Location status: Recruiting
NCT Number: NCT07309718
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Beijing, Xicheng District, 100053, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines
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.
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.
Time frame: 12 months
the number of participants who suffer from TIA related to ischemia in the qualifying artery territory within 1 year
Time frame: 12 months
the number of participants who suffer from any stroke/TIA/ death 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
Time frame: 12 months
the number of participants who suffer from embolic stroke within in the qualifying artery territory 1 year
Contact information is provided by the study sponsor or research team.
Xuanwu Hospital, Beijing
Other
MRI-Derived Pressure Ratio: a Novel Noninvasive Hemodynamic Biomarker for Stroke Risk Stratification in Intracranial Atherosclerotic Stenosis
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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