Ultra-early detection of failed recovery after stroke using cerebral autoregulation during thrombectomy

Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring: a Multicenter, Prospective, Observational Study

This study tests whether monitoring how the brain controls blood flow during thrombectomy can quickly show which large-vessel ischemic stroke patients are unlikely to regain function after a successful vessel reopening.

Quick facts

• Study type: Observational
• Enrollment: 129 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Shijitan Hospital, Capital Medical University (other)
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT07556068 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective observational diagnostic accuracy study that records cerebral autoregulation (CA) measures during endovascular thrombectomy in adults with anterior-circulation large-vessel occlusion. Researchers will enroll 129 participants split into modeling and validation cohorts and follow clinical outcomes at 24 and 48 hours, 7 days (or discharge), and 90 days. The primary aim is to determine whether intraoperative CA impairment predicts futile recanalization—poor functional outcome despite achieving mTICI 2b-3 reperfusion. No experimental therapies are given; CA metrics will be linked to clinical outcomes to build and test predictive models.

Who should consider this trial

Good fit: Adults (≥18) with acute anterior-circulation large-vessel occlusion undergoing thrombectomy within 24 hours, NIHSS ≥6, pre-stroke mRS ≤1, and meeting ASPECTS/time criteria who provide consent are eligible.

Not a fit: Patients with multiple-territory strokes, arterial dissection, posterior-circulation strokes, those who do not achieve adequate recanalization, or those treated outside the participating centers/time windows are unlikely to benefit from the monitoring approach tested here.

Why it matters

Potential benefit: If successful, this approach could allow teams to identify at-risk patients during the procedure and offer targeted rescue or neuroprotective measures to improve outcomes.

How similar studies have performed: Prior observational work has linked impaired cerebral autoregulation to worse stroke outcomes, but CA-based ultra-early prediction of futile recanalization during thrombectomy has not been fully validated.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18
2. Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
3. NIHSS score ≥ 6 obtained prior to endovascular treatment.
4. Modified Rankin Scale ≤ 1 prior to qualifying stroke.
5. Acute ischemic stroke, undergone endovascular treatment within 24 hours of onset (time of stroke is the last known normal for wake-up stroke or with unknown onset time).with reaching the goal of mTICI grade 2b-3
6. For patients with symptom onset within 6 hours: ASPECTS ≥ 3; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3.
7. Patient/Legally Authorized Representative has signed the Informed Consent Form.

Exclusion Criteria:

1. Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
2. Baseline CT/MRI confirms the presence of arterial dissection.
3. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
4. Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
5. Severe infection (e.g. sepsis) or multiple organ failure.
6. Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency; oral anticoagulant therapy with INR \> 3; or use of a factor Xa inhibitor within the preceding 48 hours with an abnormal aPTT.
7. Baseline platelet count \< 50 × 10\^9/L.
8. Blood glucose concentration\<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L).
9. Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg).
10. Severe cardiomyopathy with heart failure (LVEF ≤ 30% or NYHA class IV), acute myocardial infarction, or unstable angina.
11. Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
12. Current hemodialysis or peritoneal dialysis; known severe renal insufficiency with estimated glomerular filtration rate \< 30 mL/min or serum creatinine \> 220 μmol/L (2.5 mg/dL).
13. Known intracranial aneurysm, and cerebral arteriovenous malformation.
14. Malignant brain tumor or CNS infection.
15. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
16. Female who is pregnant or lactating at time of admission.
17. Anticipated life expectancy \< 6 months.
18. Current participation in another investigational drug or device study.
19. local skin damage or other conditions that cannot cooperate with electrode sticking.
20. severe agitation or other conditions affecting data collection.

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• Beijing Shijitan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (RECRUITING)
• Dalian Municipal Central Hospital — Dalian, Liaoning, China (NOT_YET_RECRUITING)
• Weifang People's Hospital Affiliated to Weifang Medical University — Weifang, Shandong, China (RECRUITING)

Study contacts

• Principal investigator: Shen Li — Beijing Shijitan Hospital, Capital Medical University
• Study coordinator: Zidong Li

Conditions: Acute Ischemic Stroke, Cerebral Autoregulation