Clinical trial NCT05670028: Cerebral Autoregulation Guiding Blood Pressure Management After Revascularization
Official title: Cerebral Hemodynamic Management Based on Cerebral Autoregulation Monitoring in Acute Ischemic Stroke Patients After Endovascular Treatment: a Multicenter, Open-label, Randomized Control Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Ischemic Stroke
Revascularization
Blood Pressure
Cerebrovascular Insufficiency
Cerebral Autoregulation
Individuation
Hemorrhagic Transformation Due to Acute Stroke
Keywords: Ischemic Stroke
Revascularization
Blood Pressure
Cerebral Autoregulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Early neurological recovery
timeFrame: Seven days after endovascular therapy (or on the discharge if less than seven days)
Secondary outcomes:
measure: The proportion of functional independence with modified Rankin Scale scores 0-2
timeFrame: 90 days after endovascular therapy
measure: Distribution of modified Rankin Scale scores ranging from 0-6
timeFrame: 90 days after endovascular therapy
measure: Infarct volume growth
timeFrame: Seven days after endovascular therapy (or on the discharge if less than seven days)
Other outcomes:
measure: (Safety outcome) Symptomatic hemorrhagic transformation
timeFrame: Within 48 hours after endovascular therapy (or on the discharge if less than 48 hr)
measure: (Safety outcome) All-cause death
timeFrame: Within 90 days after endovascular therapy
Locations:
Study officials:
References:
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