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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Shijitan Hospital, Capital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

129 Participants
are divided into 1 treatment group
Group A: Cerebral autoregulation monitoring cohort1 intervention

Trial outcomes

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.

Time frame
Month 3

Secondary outcomes

1

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

The sensitivity, specificity and area under the receiver operating characteristic curve of cerebral autoregulation coefficient in predicting early neurological improvement were calculated. "Early neurological improvement" is defined as an improvement of 8 or more points in NIHSS score or a decrease to 0-1 within 24 hours after recanalization.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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