Ischemic Stroke Clinical Trial
— RESCUE-CAOfficial title:
Cerebral Hemodynamic Management Based on Cerebral Autoregulation Monitoring in Acute Ischemic Stroke Patients After Endovascular Treatment: a Multicenter, Open-label, Randomized Control Study
Verified date | January 2023 |
Source | Beijing Tiantan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | June 4, 2026 |
Est. primary completion date | January 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Beijing Tiantan Hospital |
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | (Safety outcome) Symptomatic hemorrhagic transformation | 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) | |
Other | (Safety outcome) All-cause death | All causes of death during the follow-up | Within 90 days after endovascular therapy | |
Primary | 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 | 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). | 90 days after endovascular therapy | |
Secondary | 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). | 90 days after endovascular therapy | |
Secondary | 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. | Seven days after endovascular therapy (or on the discharge if less than seven days) |
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