Cerebral Autoregulation Guiding Blood Pressure Management After Revascularization

NCT05670028 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: RESCUE-CA
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The proportion of functional independence with modified Rankin Scale scores 0-2

  90 days after endovascular therapy

• Distribution of modified Rankin Scale scores ranging from 0-6

  90 days after endovascular therapy

• Infarct volume growth

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

Other Outcomes (2)

• (Safety outcome) Symptomatic hemorrhagic transformation

  Within 48 hours after endovascular therapy (or on the discharge if less than 48 hr)

• (Safety outcome) All-cause death

  Within 90 days after endovascular therapy

Study Arms (2)

CA-guided BP

EXPERIMENTAL

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

Fixed target BP

ACTIVE COMPARATOR

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

Interventions

Hypotensive Drugs and/or Vasoactive Drugs DRUG

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).

CA-guided BP; Fixed target BP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Related Publications (14)

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MeSH Terms

Conditions

Ischemic Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 4, 2023
• Study Start: June 4, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 4, 2026
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share