A randomized trial on Hemodynamic Optimization of cerebral Perfusion after Endovascular therapy in patients with acute ischemic stroke (HOPE study)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 814
- 试验地点
- 15
- 主要终点
- Direct comparison between the two arms of the trial with respect to mRS score at 90 days after randomization. This will be an intention to treat analysis. The main effect parameter will be the OR of change (shift analysis) in the direction of a better result in the mRS with its 95% confidence interval.
研究概览
简要总结
Compare the clinical benefit of standard blood pressure management after mechanical thrombectomy versus a specific protocol aimed at hemodynamic optimization, where blood pressure targets are applied based on the degree of recanalization achieved during the procedure.
Compare the clinical benefit of standard blood pressure management after mechanical thrombectomy versus a specific protocol aimed at hemodynamic optimization, where blood pressure targets are applied based on the degree of recanalization achieved during the procedure.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with acute ischemic stroke and large intracranial vessel occlusion within 24 hours of symptom onset who have undergone mechanical thrombectomy.
- •Successful recanalization, defined as a TICI score of 2b, 2c, or
- •Prior score on the modified Rankin Scale (mRS) of 0, 1, or
- •The patient or their legal representative provides informed consent in writing or verbally.
排除标准
- •ASPECTS score < 6
- •Inclusion in other clinical trials.
- •Occlusion in the vertebral, basilar, A2, P2, and M3-4 arteries.
- •History of intracerebral hemorrhage
- •Pregnant or lactating patient
- •Patient with congestive heart failure or unstable or recent coronary artery disease (<3 months)
- •Dissection of the aorta, cervical, or cerebral arteries, or unruptured aortic/cerebral aneurysm or known arteriovenous malformation
- •Any visible hemorrhage on the initial CT scan
- •History of ventricular arrhythmias
- •Use of MAO inhibitors
结局指标
主要结局
Direct comparison between the two arms of the trial with respect to mRS score at 90 days after randomization. This will be an intention to treat analysis. The main effect parameter will be the OR of change (shift analysis) in the direction of a better result in the mRS with its 95% confidence interval.
Direct comparison between the two arms of the trial with respect to mRS score at 90 days after randomization. This will be an intention to treat analysis. The main effect parameter will be the OR of change (shift analysis) in the direction of a better result in the mRS with its 95% confidence interval.
次要结局
未报告次要终点
研究者
UICEC Sant Pau
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau