Back to resultsCerebral Autoregulation Guiding Blood Pressure Management After Revascularization (RESCUE-CA)
Primary Purpose
Ischemic Stroke, Revascularization, Blood Pressure
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hypotensive Drugs and/or Vasoactive Drugs
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Revascularization, Blood Pressure, Cerebral Autoregulation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CA-guided BP
Fixed target BP
Arm 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.
After randomization to 48h after endovascular therapy, the target of BP was determined by clinicians according to current guidelines, i.e. <180/105mmHg.
Outcomes
Primary Outcome Measures
Early neurological recovery
the NIHSS score decreased by ≥ 4 from the preoperative baseline
Secondary Outcome Measures
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).
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).
Infarct volume growth
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.
Full Information
NCT ID
NCT05670028
First Posted
January 2, 2023
Last Updated
January 4, 2023
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05670028
Brief Title
Cerebral Autoregulation Guiding Blood Pressure Management After Revascularization
Acronym
RESCUE-CA
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 4, 2023 (Anticipated)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
June 4, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Revascularization, Blood Pressure, Cerebrovascular Insufficiency, Cerebral Autoregulation, Individuation, Hemorrhagic Transformation Due to Acute Stroke
Keywords
Ischemic Stroke, Revascularization, Blood Pressure, Cerebral Autoregulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CA-guided BP
Arm Type
Experimental
Arm 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.
Arm Title
Fixed target BP
Arm Type
Active Comparator
Arm Description
After randomization to 48h after endovascular therapy, the target of BP was determined by clinicians according to current guidelines, i.e. <180/105mmHg.
Intervention Type
Drug
Intervention Name(s)
Hypotensive Drugs and/or Vasoactive Drugs
Intervention Description
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).
Primary Outcome Measure Information:
Title
Early neurological recovery
Description
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 Outcome Measure Information:
Title
The proportion of functional independence with modified Rankin Scale scores 0-2
Description
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
Title
Distribution of modified Rankin Scale scores ranging from 0-6
Description
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).
Time Frame
90 days after endovascular therapy
Title
Infarct volume growth
Description
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.
Time Frame
Seven days after endovascular therapy (or on the discharge if less than seven days)
Other Pre-specified Outcome Measures:
Title
(Safety outcome) Symptomatic hemorrhagic transformation
Description
Hemorrhagic transformation graded PH-2 (ECASS) with an increase of NIHSS score ≥ 4 compared to baseline
Time Frame
Within 48 hours after endovascular therapy (or on the discharge if less than 48 hr)
Title
(Safety outcome) All-cause death
Description
All causes of death during the follow-up
Time Frame
Within 90 days after endovascular therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Cerebral Autoregulation Guiding Blood Pressure Management After Revascularization
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