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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Shijitan Hospital, Capital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18

Diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (intracranial internal carotid artery or M1 segment of the middle cerebral artery).

National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation.

Pre-stroke modified Rankin Scale (mRS) score ≤ 1.

Disqualifiers

Pre-procedural baseline imaging showing significant intracranial hemorrhagic transformation, intracranial arterial dissection, large chronic cerebral infarction, or intracranial metastasis from malignant tumors.

Any degree of stenosis, plaque, dissection, severe tortuosity, or imaging evidence of unstable/vulnerable plaque in the target-side or bilateral common carotid artery or the origin of the internal carotid artery.

Known history of carotid sinus hypersensitivity syndrome, severe autonomic dysfunction, sick sinus syndrome, high-grade atrioventricular conduction block, or other malignant arrhythmias.

Refractory malignant hypertensive crisis (systolic blood pressure persistently ≥ 200 mmHg despite standardized intravenous antihypertensive therapy, or hemodynamic instability with shock).

Trial design

Design model

Single group

Treatments tested in this trial

  • NIRS-based cerebral oxygenation and blood pressure monitoring

    Device

    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.

  • Carotid compression test

    Procedure/Surgery

    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.

Treatment groups

227 Participants
are divided into 1 treatment group
Group A: Cerebral Autoregulation Monitoring After Mechanical ThrombectomyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Distribution of Modified Rankin scale

the distribution of Modified Rankin scale (mRS) \[ranging from 0 (normal) to 6 (death)\]

Time frame
90±7days

Secondary outcomes

1

Early neurological improvement

Early neurological improvement is defined as a reduction of ≥8 on the National Institutes of Health Stroke Scale \[ranging from 0 to 42 points, with higher numbers indicating greater severity\] or National nstitutes of Health Stroke Scale zero to one 24 hours after thrombectomy.

Time frame
24±12 hours

Other outcomes

Sponsors and contacts

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