Cerebral Hemodynamic Management Based on Cerebral Autoregulation Monitoring in Acute Ischemic Stroke Patients After Endovascular Treatment: a Multicenter, Open-label, Randomized Control Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Early neurological recovery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: Hypotensive Drugs and/or Vasoactive Drugs (Drug)
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.
干预措施: Hypotensive Drugs and/or Vasoactive Drugs (Drug)
结局指标
主要结局
Early neurological recovery
时间窗: Seven days after endovascular therapy (or on the discharge if less than seven days)
the NIHSS score decreased by ≥ 4 from the preoperative baseline
次要结局
- Infarct volume growth(Seven days after endovascular therapy (or on the discharge if less than seven days))
- Distribution of modified Rankin Scale scores ranging from 0-6(90 days after endovascular therapy)
- The proportion of functional independence with modified Rankin Scale scores 0-2(90 days after endovascular therapy)
研究者
Liping Liu
Professor
Beijing Tiantan Hospital