Actively Recruiting
Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring: a Multicenter, Prospective, Observational Study
Led by Beijing Shijitan Hospital, Capital Medical University · Updated on 2026-05-06
129
Participants Needed
4
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating whether monitoring cerebral autoregulation during thrombectomy can serve as an early sign to predict futile recanalization in patients with acute ischemic stroke. This multicenter, prospective, observational diagnostic accuracy study focuses on patients undergoing thrombectomy for large-vessel occlusion stroke, aiming to improve early identification to guide personalized treatment strategies and potentially reduce adverse outcomes. Participants undergoing thrombectomy will have their cerebral autoregulation assessed intraoperatively using near-infrared spectroscopy (NIRS) combined with continuous blood pressure monitoring. This monitoring is part of routine care and helps analyze cerebral oxygen saturation and arterial blood pressure to evaluate autoregulation status. The study includes a modeling cohort and a validation cohort to develop and confirm a predictive model for futile recanalization. Participants will be evaluated face-to-face at approximately 24, 48 hours, and 7 days after enrollment or discharge, with a follow-up assessment conducted by telephone or in person at around 90 days. The primary outcomes measured are the sensitivity, specificity, and accuracy of cerebral autoregulation impairment in predicting futile recanalization, based on functional independence scores. Secondary outcomes include neurological improvement assessments at one day post-treatment, with ongoing safety and functional evaluations throughout the study period.
CONDITIONS
Brief Title
Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Clinical signs of acute ischemic stroke with large vessel occlusion in the anterior circulation confirmed by imaging
- National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher before treatment
- Modified Rankin Scale score of 1 or less before the qualifying stroke
- Underwent endovascular treatment within 24 hours of stroke onset with successful recanalization (mTICI grade 2b-3)
- For symptom onset within 6 hours: ASPECTS score of 3 or higher
- For symptom onset between 6 and 24 hours: age 80 years or younger and ASPECTS score of 3 or higher
- Signed informed consent by patient or legally authorized representative
You will not qualify if you...
- Presence of multiple acute strokes in different vascular territories confirmed by CT or MRI
- Arterial dissection confirmed by baseline imaging
- Intracranial hemorrhage or hemorrhagic transformation before thrombectomy
- Known allergies or intolerances to antiplatelet agents, anticoagulants, iodinated contrast, or anesthetics
- Severe infection such as sepsis or multiple organ failure
- Known bleeding disorders or coagulation factor deficiencies, including high INR or recent use of factor Xa inhibitors with abnormal aPTT
- Low platelet count below 50 x 10^9/L
- Blood glucose levels below 50 mg/dL or above 400 mg/dL
- Uncontrolled high blood pressure despite medication
- Severe heart failure, recent heart attack, or unstable angina
- Untreated moderate or severe coronary artery narrowing or previous coronary artery bypass surgery
- Current dialysis or severe kidney impairment
- Known intracranial aneurysm or cerebral arteriovenous malformation
- Malignant brain tumor or central nervous system infection
- Pre-existing neurological or psychiatric conditions that interfere with assessments
- Pregnant or breastfeeding women at time of admission
- Life expectancy less than 6 months
- Participation in another investigational drug or device study
- Skin issues or other conditions preventing electrode placement
- Severe agitation or conditions that affect data collection
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of thrombectomy
Participants undergo intraoperative cerebral autoregulation monitoring during thrombectomy using near-infrared spectroscopy combined with continuous blood pressure monitoring as part of routine clinical care.
1 visit (in-person)
Duration - 7 ± 3 days
Participants receive face-to-face assessments to monitor neurological status and cerebral autoregulation at multiple timepoints after enrollment.
3 visits (in-person) at 24 ± 12 hours, 48 ± 12 hours, and 7 ± 3 days post-enrollment or at discharge
Duration - Approximately 3 months
Participants have a follow-up assessment conducted via telephone or in-person interview to evaluate outcomes at 90 ± 7 days post-enrollment.
1 follow-up visit (telephone or in-person)
Trial Site Locations
Total: 4 locations
1
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
3
Dalian Municipal Central Hospital
Dalian, Liaoning, China
Not Yet Recruiting
4
Weifang People's Hospital Affiliated to Weifang Medical University
Weifang, Shandong, China
Actively Recruiting
Research Team
Z
Zidong Li
S
Shen Li
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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