Cerebral Autoregulation Guiding Blood Pressure Management After Revascularization

Phase 2Not Yet RecruitingNCT05670028

Beijing Tiantan Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Ischemic Stroke Revascularization Blood Pressure Cerebrovascular Insufficiency Cerebral Autoregulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Early neurological recovery

the NIHSS score decreased by ≥ 4 from the preoperative baseline

Time frame: Seven days after endovascular therapy (or on the discharge if less than seven days)

Secondary Outcomes

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).

Time frame: 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).