Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2): A Pilot Randomised Controlled Phase II Trial Evaluating Remote Ischaemic Conditioning (RIC) After Hyperacute Stroke 2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Trial feasibility
研究概览
简要总结
Stroke has an enormous impact on both individual and society. Novel treatments are required to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be neuroprotective and help restore functional outcome when compared to control. These outcomes are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very soon after the stroke occurs. The mechanisms of protection are unclear but may be due enhancing the body's ability to protect itself from further injury by favorably altering cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic conditioning (IC) is an intervention already applied during cardiac surgery to protect the heart from damage and it may be effective after an acute myocardial infarction. The investigators therefore plan to conduct a pilot randomised controlled trial assessing the feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC. Secondary outcomes include tolerability, safety and clinical efficacy. The results will inform the design of future trials of a potential intervention is that is pragmatic, non-invasive and simple to administer.
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
- Double (Participant, Outcomes Assessor)
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
- •Suspected clinical stroke with 6 hours of onset of neurological symptoms;
- •Written or witnessed oral consent, or relative/consultee advice.
排除标准
- •Pre-morbid dependency mRS>3;
- •Coma (GCS< 8);
- •Malignancy or significant co-morbidity thought to limit life expectancy to <6 months;
- •Blood sugar < 3.5 mmol/L;
- •Taking part in another clinical trial of an investigational medicinal product (CTIMP);
研究组 & 干预措施
Remote Ischaemic Conditioning
Remote ischaemic conditioning (RIC group): 4 cycles of intermittent limb ischaemia - alternating 5 minutes inflation (20mmHg above systolic BP) followed by 5 minutes deflation of a standard upper arm blood pressure cuff
干预措施: Remote ischaemic conditioning (Procedure)
Control
Control: 4 cycles of alternating 5 minutes inflation (up to 30 mmHg) followed by 5 minutes deflation of a standard upper arm blood pressure cuff
干预措施: Sham (Procedure)
结局指标
主要结局
Trial feasibility
时间窗: 90 days
Recruitment feasibility (recruitment rate)
次要结局
- Disability(Day 90±7)
- Impairment(Day 4±1, day 90±7)
- Dependency(Day 90±7)
- Vascular Event Rate [Safety and Tolerability](Day 1, Day 4±1, day 90±7)
- Mood(Day 90±7)
- Treatment Related Serious Adverse Event Rates [Safety and Tolerability](Day 1, Day 4±1, day 90±7)
- Telephone cognition(Day 90±7)
- Biomarkers(Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1)
