NCT05028855

Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 850 (estimated)
• Sponsor: Yi Yang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this multi-center prospective observational study within a cohort of symptomatic cerebral atherosclerotic stenosis (sCAS) patients, 850 subjects were planed to be enrolled to explore the relationship between cerebral autoregulation (CA) and stroke recurrence, determine the threshold values of CA parameter for predicting stroke recurrence associated with particular stenosis.

Detailed description

Ischemic stroke is a tremendous public health burden that seriously endangers the health of Chinese population symptomatic cerebral atherosclerotic stenosis (sCAS) is responsible for about 33-50% of ischemic stroke in China and highly associated with the risk of stroke recurrence. Cerebral autoregulation (CA) is the main protective mechanism that modulates cerebral blood flow to satisfy regional cerebral perfusion demands despite of variations in arterial blood pressure (ABP). Thus, CA supposed to be particularly considered when choosing individual therapeutic strategy in sCAS patients. In clinical practice, applying transcranial Doppler combined with servo-controlled plethysmograph assessing CA has been proved a feasible method in cerebral atherosclerotic stenosis patients. Especially in those severe stenosis patients, CA is probably compromised in varying degrees, whereas whether and to what extent CA parameters have the capability to predict stroke recurrence has not been illustrated. Thus, the aim of the study was to assess CA after acute ischemic stroke or transient ischemic attack within 2 years follow-up to explore the relationship between CA and stroke recurrence and determine the threshold values of CA parameter to predict stroke recurrence. CA measurement will be performed at 0-3 and 10-30 days after ischemic cerebrovascular events. Clinical information, neuroimaging data, biochemical examinations and follow-up information will be collected and recorded in case report form (CRF) once signing of informed consent.

Conditions

• Cerebrovascular Stroke
• Cerebral Artery Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cerebral autoregulation assessment	Cerebral autoregulation assessment will be conducted by specialized neurovascular ultrasound doctors during 0-3 and 10-30 days after stroke onset.The recorded data will be stored for further cerebral autoregulation analysis.

Timeline

• Start date: 2017-01-14
• Primary completion: 2025-12-24
• Completion: 2026-08-30
• First posted: 2021-08-31
• Last updated: 2024-03-01

Locations

1 site across 1 country: China