IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke:A Feasibility Study of Randomisation to Individual vs. Fixed Blood Pressure Targets During Endovascular Therapy for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death)
研究概览
简要总结
The ideal blood pressure management strategy during endovascular therapy (EVT) for acute ischemic stroke has not been defined. The aim of this pilot randomized clinical trial is to determine whether randomization to a standard versus individual blood pressure management strategy during the EVT procedure is feasible.
详细描述
Acute ischemic stroke (AIS) is a leading cause of death and long-term disability in the Western world. Catheter-based removal of blood clots (endovascular therapy-EVT) is now the standard of care for AIS caused by large vessel occlusions in the brain. The level of blood pressure during the procedure appears to influence outcome. However, optimal blood pressure management strategy has not been determined. Current blood pressure management strategy during EVT typically aims to maintain blood pressure above or within predefined fixed targets and is based on observational data and expert consensus rather than on high-quality randomized evidence. Should blood pressure during removal of the occlusion be managed according to the patient's individual blood pressure level or according to predefined fixed blood pressure targets? The primary aim of this pilot trial is to determine whether randomization to a procedure strategy targeting a predefined mean arterial blood pressure (MABP) of 70-90 mmHg versus an individual strategy targeting ± 10 % of a MABP reference value is feasible. Secondary aims are to test recruitability and to detect challenges or obstacles that would call for changes in the study design.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Large vessel occlusion in anterior circulation in patients deemed treatable with EVT.
- •Living independently (mRS < 2) before stroke.
- •EVT procedure feasible within 24 hours of symptom onset.
排除标准
- •Contra-indication/allergy to contrast agents, vasopressor agents or anaesthetics.
- •Pregnancy.
- •Medical condition where blood pressure targeting will be problematic (aorta dissection, etc).
- •Participation in another trial.
结局指标
主要结局
3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death)
时间窗: Assessed up to 3 months after endovascular treatment
Functional outcome measure
次要结局
- Recruitment rate (percentage)(Assessed up 3 months after endovascular treatment)
- Adherence to mean arterial blood pressure targets. Specifically, to determine the percentage of time outside the target treatment range(Assessed 3 months after endovascular treatment)
- Data completeness (percentage)(Assessed up to 3 months after endovascular treatment)
- Degree of reperfusion(Assessed up to 3 months after endovascular treatment)
