A Multi-centre, Randomized, Controlled Study of External Counterpulsation for Patients with Recent Atherosclerotic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 试验地点
- 1
- 主要终点
- Combined endpoint ("good outcome") at 12 weeks defined as the overall surviving patients with mRS 0-2 (i.e. Bad outcome as death or mRS 3-5).
研究概览
简要总结
To determine the effect of External Counterpulsation for Patients with Recent Atherosclerotic Stroke. It uses sequential air cuffs filling in the calf, thigh and buttock to enhance diastolic pressure. It has been approved for the treatment of refractory angina worldwide. Its mechanism of action is thought to be diversion of blood from the lower extremities to the heart and brain and also promote collateral. In this proposal, we aim to confirm the efficacy and safety of external counterpulsation for the treatment of stroke patients with ischemic of atherosclerotic origin. Patients will be randomized to receive 35 one-hour sessions of ECP or no ECP, in addition to best available evidence-based medical and rehabilitation treatment.Neurological deficit, disability, recurrent events and safety will be documented on randomisation and 12 weeks after stroke onset.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Subject is aged not less than 18;
- •Subject is presented with clinical diagnosis of ischaemic stroke according to the WHO criteria;
- •Recent ischemic stroke is within 7 days of symptom onset;
- •Subject is found to have motor deficit as a result of stroke;
- •Subject has brain CT performed and results confirmed no evidence of intracerebral haemorrhage;
- •NIHSS is between 4 and 16 inclusive;
- •Pre-stroke mRS 0-1;
- •Evidence of large artery occlusive disease. If no diagnostic procedure is done before randomization, neuroimaging should be done within 3 days of randomisaton;
- •Subject or his/her legally acceptable representative is willing to provide written informed consent.
排除标准
- •Subject is aged less than 18;
- •Subject has evidence for cardioembolic stroke such as atrial fibrillation and rheumatic heart disease;
- •Subject has evidence for haemorrhage on brain CT;
- •Subject has a history of intracerebral haemorrhage;
- •Subject has evidence for AVMs, AV fistula or aneurysm;
- •Subject has active malignancy;
- •Subject has no definite motor deficit;
- •Subject has a National Institutes of Health Stroke Scale (NIHSS) of less than 4 or greater than 16;
- •Subject has sustained hypertension (systolic >180mmHg or diastolic >100mmHg);
- •Subject is unlikely to be followed up at Week 12;
- •Subject has co-existing systemic diseases: renal failure (creatinine >300 umol/L, if known), cirrhosis, severe dementia or psychosis;
- •Subject has brain tumour or other significant non-ischaemic brain lesion on CT;
- •Subject has thrombocytopenia (platelet count<100,000/mm3, if known);
- •Subject is a pregnant female, a breast-feeding mother, is planning pregnancy during the course of the trial or has a positive urine pregnancy test immediately prior to randomisation;
- •Subject is participating in another clinical trial within 30 days before randomisation;
- •Subject or his/her legally acceptable representative is unwilling to provide written informed consent.
研究组 & 干预措施
Two groups
结局指标
主要结局
Combined endpoint ("good outcome") at 12 weeks defined as the overall surviving patients with mRS 0-2 (i.e. Bad outcome as death or mRS 3-5).
次要结局
- NIHSS(at end of Week 7 & 12)
- Modified Rankin Scale(at Week 7 & 12)
- Barthel Index(at Week 7 & 12)
- Mini-Mental State Examination(at Week 7 & 12)
- Overall mortality(at Week 12)
- Predefined group of patients with large artery disease and for all randomized patients (including those later find to have no LAD)
- Prespecified patient "on-treatment analysis" who at least 25 ECP sessions