Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation

NCT07556068 | Recruiting

• 1 other identifier: CAREFUL-CA
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 4

Brief Summary

This multicenter, prospective, observational 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. The study aims to determine whether impaired cerebral autoregulation during thrombectomy can serve as an ultra-early biomarker for predicting futile recanalization in patients with acute ischemic stroke.

Conditions

Acute Ischemic Stroke; Cerebral Autoregulation

Outcome Measures

Primary Outcomes (1)

• The sensitivity, specificity and area under the receiver operating characteristic curve for percentage of Modified Rankin scale 0-2

  "Futile recanalization" is defined as a poor neurological prognosis (90-day Modified Rankin scale \> 2) in patients with acute large vessel occlusion ischemic stroke who have achieved good recanalization grade (mTICI≥2b) after endovascular treatment. The sensitivity, specificity and area under the receiver operating characteristic curve of cerebral autoregulation coefficient in predicting the percentage of mRS scale 0-2 (Modified Rankin scale \[ranging from 0 (normal) to 6 (death) were calculated.

  Month 3

Secondary Outcomes (1)

• The sensitivity, specificity and area under the receiver operating characteristic curve for early neurological improvement

  Day 1

Study Arms (1)

Cerebral autoregulation monitoring cohort

The consecutively enrolled participants undergoing thrombectomy for acute ischemic stroke. Intraoperative cerebral autoregulation will be assessed using near-infrared spectroscopy (NIRS)-based cerebral oxygen saturation monitoring combined with continuous blood pressure monitoring (noninvasive or invasive). This cohort will be used to develop the predictive and validate model for futile recanalization.

Diagnostic Test: diagnostic accuracy study

Interventions

diagnostic accuracy study DIAGNOSTIC_TEST

Cerebral autoregulation is assessed intraoperatively during thrombectomy using near-infrared spectroscopy (NIRS)-derived cerebral oxygen saturation combined with continuous noninvasive or invasive arterial blood pressure monitoring. The correlation between cerebral oxygen saturation and arterial blood pressure is analyzed to quantify cerebral autoregulation status. This monitoring is performed as part of routine clinical care and does not constitute an additional research intervention.

Cerebral autoregulation monitoring cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke due to anterior circulation large-vessel occlusion who undergo mechanical thrombectomy within 24 hours of the last known normal time, achieving successful recanalization (mTICI ≥ 2b).

You may qualify if:

• Age ≥ 18
• 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.
• NIHSS score ≥ 6 obtained prior to endovascular treatment.
• Modified Rankin Scale ≤ 1 prior to qualifying stroke.
• 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
• 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.
• Patient/Legally Authorized Representative has signed the Informed Consent Form.

You may not qualify if:

• Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
• Baseline CT/MRI confirms the presence of arterial dissection.
• Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
• Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
• Severe infection (e.g. sepsis) or multiple organ failure.
• 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.
• Baseline platelet count \< 50 × 10\^9/L.
• Blood glucose concentration\<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L).
• Refractory hypertension that is difficult to control by medication (Defined as persistent systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg).
• Severe cardiomyopathy with heart failure (LVEF ≤ 30% or NYHA class IV), acute myocardial infarction, or unstable angina.
• Untreated moderate or severe coronary artery stenosis, or previous coronary artery bypass surgery.
• 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).
• Known intracranial aneurysm, and cerebral arteriovenous malformation.
• Malignant brain tumor or CNS infection.
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University: lead

Study Sites (4)

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

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shen Li

  Beijing Shijitan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zidong Li

CONTACT

010-63925615; walx592815088@163.com

Shen Li

CONTACT

010-63925616; lishen@mail.ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 29, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)