Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring
NCT07747701 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227
Last updated 2026-08-05
Summary
This multicenter, prospective, and interventional diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.
Conditions
- Acute Ischemic Stroke
- Cerebral Autoregulation
Interventions
- DEVICE
-
NIRS-based cerebral oxygenation and blood pressure monitoring
Bedside multimodal cerebral autoregulation monitoring performed immediately after successful mechanical thrombectomy (mTICI 2b-3). Monitoring includes continuous near-infrared spectroscopy (NIRS) to record cerebral oxygen saturation and continuous noninvasive or invasive arterial blood pressure measurement for 25-30 minutes. Cerebral oxygenation index (COx) is calculated as a moving Pearson correlation coefficient between mean arterial pressure and cerebral oxygen saturation over 30 consecutive 10-second epochs (300 seconds). COx ≥ 0.3 indicates impaired cerebral autoregulation, while COx \< 0.3 indicates preserved autoregulation. Changes in cerebral oxygen saturation before and after carotid compression are also used to assess autoregulatory.
- PROCEDURE
-
Carotid compression test
A carotid compression test is performed by compressing the common carotid artery at the lower one-third of the neck (avoiding the carotid sinus) against the transverse process of C6 until pulsation disappears for 5-10 seconds, followed by release. If the brain oxygen saturation has increased compared to before the test, it indicates that the brain's automatic blood flow regulation function is intact; conversely, if it has decreased, it is regarded as a damaged automatic blood flow regulation function of the brain.
Sponsors & Collaborators
-
Beijing Shijitan Hospital, Capital Medical University
lead OTHER
Principal Investigators
-
Shen Li · Beijing Shijitan Hospital, Capital Medical University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2027-01-31
- Completion
- 2027-02-05
Countries
- China
Study Locations
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