Blood Pressure, Cerebral Autoregulation, Cerebrovascular Insufficiency, Hemorrhagic Transformation Due to Acute Stroke, Individuation, Ischemic Stroke, Revascularization
Conditions
Keywords
Ischemic Stroke, Revascularization, Blood Pressure, Cerebral Autoregulation
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.
Interventions
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).
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early neurological recovery | Seven days after endovascular therapy (or on the discharge if less than seven days) | the NIHSS score decreased by ≥ 4 from the preoperative baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of functional independence with modified Rankin Scale scores 0-2 | 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). |
| Distribution of modified Rankin Scale scores ranging from 0-6 | 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). |
| Infarct volume growth | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| (Safety outcome) Symptomatic hemorrhagic transformation | 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 |
| (Safety outcome) All-cause death | Within 90 days after endovascular therapy | All causes of death during the follow-up |
Outcome results
None listed