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

January 4, 2023 updated by: Liping Liu, Beijing Tiantan Hospital

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CA-guided BP
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
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).
Active Comparator: Fixed target BP
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early neurological recovery
Time Frame: Seven days after endovascular therapy (or on the discharge if less than seven days)
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
Infarct volume growth
Time Frame: Seven days after endovascular therapy (or on the discharge if less than seven days)
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)
The proportion of functional independence with modified Rankin Scale scores 0-2
Time Frame: 90 days after endovascular therapy
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
Time Frame: 90 days after endovascular therapy
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Safety outcome) Symptomatic hemorrhagic transformation
Time Frame: Within 48 hours after endovascular therapy (or on the discharge if less than 48 hr)
Hemorrhagic transformation graded PH-2 (ECASS) with an increase of NIHSS score ≥ 4 compared to baseline
Within 48 hours after endovascular therapy (or on the discharge if less than 48 hr)
(Safety outcome) All-cause death
Time Frame: Within 90 days after endovascular therapy
All causes of death during the follow-up
Within 90 days after endovascular therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 4, 2023

Primary Completion (Anticipated)

January 31, 2026

Study Completion (Anticipated)

June 4, 2026

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCUE-CA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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