Cerebral Autoregulation Guiding Blood Pressure Management After Revascularization

Study Overview
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Brief Summary
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This clinical trial aims to learn whether blood pressure (BP) guided by individualized cerebral autoregulation (CA) is safe and provides a better prognosis than a fixed target in patients with ischemic stroke after endovascular therapy. The BP of participants will be managed at least 48 hours after revascularization. Researchers will compare the CA-guided BP group with the fixed target BP group to mainly see if individualized BP could help more patients to have their neurological function improved at seven days.

Official Title
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Cerebral Hemodynamic Management Based on Cerebral Autoregulation Monitoring in Acute Ischemic Stroke Patients After Endovascular Treatment: a Multicenter, Open-label, Randomized Control Study

Conditions
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Ischemic Stroke, Revascularization, Blood Pressure, Cerebrovascular Insufficiency, Cerebral Autoregulation, Individuation, Hemorrhagic Transformation Due to Acute Stroke

Intervention / Treatment
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* Drug: Hypotensive Drugs and/or Vasoactive Drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 No functional disability before stroke (mRS 0-1) Angiography (CTA, MRA or DSA) before endovascular therapy confirmed occlusion of the internal carotid artery and/or the middle cerebral artery M1 to M2 segment, with consistent clinical symptoms. Informed consent is given by the patient or the legal representative. Exclusion Criteria: Hemorrhagic transformation with mass effect (PH-2 type parenchymal hematoma) occurs during the operation. Coma, dilated pupils on one or both sides, dull or absent light reflex is noticed before randomization Dissection of aorta, common carotid artery, internal carotid artery, subclavian artery, intracranial artery; severe bilateral subclavian artery stenosis; contraindications of radial artery puncture were found before or during surgery. Shock. Severe cardiomyopathy with heart failure (EGFR ≤ 30% or NYHA Grade IV), acute myocardial infarction, or unstable angina. Possible infective endocarditis, infective embolism, or vasculitis. Participating in other clinical research involving drug or device intervention after endovascular therapy. Women who plan or are pregnant, or breastfeeding. Severe liver or kidney disease, malignant tumor with a life expectancy is less than 3 months. The 90-day follow-up is not expected to be completed.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CA-guided BP<br>The upper and lower limits of autoregulation determined by ICM+ software are used to guide the range of blood pressure control, but no more than 40% above or below the usual BP. From when the upper or lower limit of autoregulation appeared in ICM+ software to 48h after revascularization, the total time of actual BP beyond the CA range will be no more than two hours through drug intervention. | Drug: Hypotensive Drugs and/or Vasoactive Drugs<br>* To manipulate the blood pressure within a certain range with hypotensive drugs (e.g. nifedipine, benidipine, captopril, benazepril, irbesartan, labetalol, urapidil) and/or vasoactive drugs (noradrenaline or dopamine).<br>|
| Active Comparator: Fixed target BP<br>After randomization to 48h after endovascular therapy, the target of BP was determined by clinicians according to current guidelines, i.e. <180/105mmHg. | Drug: Hypotensive Drugs and/or Vasoactive Drugs<br>* To manipulate the blood pressure within a certain range with hypotensive drugs (e.g. nifedipine, benidipine, captopril, benazepril, irbesartan, labetalol, urapidil) and/or vasoactive drugs (noradrenaline or dopamine).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early neurological recovery | the NIHSS score decreased by ≥ 4 from the preoperative baseline | Seven days after endovascular therapy (or on the discharge if less than seven days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of functional independence with modified Rankin Scale scores 0-2 | The Modified Rankin Scale (mRS) is a disability scale with possible scores ranging from 0 (no residual symptoms) to 6 (dead). | 90 days after endovascular therapy | 
| Distribution of modified Rankin Scale scores ranging from 0-6 | To compare the difference in the distribution of mRS scores. The Modified Rankin Scale (mRS) is a disability scale with possible scores ranging from 0 (no residual symptoms) to 6 (dead). | 90 days after endovascular therapy | 
| Infarct volume growth | The infarct volume at the preoperative baseline is defined as the area with rCBF<30% or ADC<620mm×10^-6mm^2/s via RAPID software and that at seven days is measured manually on brain CT. | Seven days after endovascular therapy (or on the discharge if less than seven days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke, Revascularization, Blood Pressure, Cerebral Autoregulation