Cerebral Autoregulation Guiding Blood Pressure Management After Revascularization (RESCUE-CA)

Capital Medical University

Status and phase: Not yet enrolling; Phase 2

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

Treatments: Drug: Hypotensive Drugs and/or Vasoactive Drugs

Study type: Interventional

Funder types: Other

Identifiers

NCT05670028

RESCUE-CA

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CA-guided BP

Experimental group

Description:

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.

Treatment:

Drug: Hypotensive Drugs and/or Vasoactive Drugs

Fixed target BP

Active Comparator group

Description:

After randomization to 48h after endovascular therapy, the target of BP was determined by clinicians according to current guidelines, i.e. \<180/105mmHg.

Treatment:

Drug: Hypotensive Drugs and/or Vasoactive Drugs