CTRI/2016/11/007495已完成2 期
Early Remote Ischaemic Conditioning in Stroke Study - ERICS
Wellcome Trust and DBT Indian Alliance0 个研究点目标入组 57 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. TIA or ischaemic stroke.
- •2. Mild-to-moderate neurological deficits (NIHSS) 0 to15
- •3. Must have a diffusion-restricted lesion on MRI prior to enrolment
- •4. Presence of at least one vascular risk factor: hypertension, diabetes mellitus, dyslipidemia, smoking, coronary artery disease, non-valvular atrial fibrillation, symptomatic intracranial or extracranial atherosclerosis disease and rheumatic heart disease.
- •5. Must have infarct size more than 70 ml in the supratentorial region on DWI (the infarct volume will be measured at the time of enrolment by ABC/2 method)
- •6. Both anterior and posterior circulation stroke syndrome are eligible. Low risk of bleed such as meningiomas,arteriovenous malformations and cavernomas may be included at the discretion of the investigator.
排除标准
- •1. Patients with premorbid disability (modified Rankin Scale greeter than 2)
- •2. Patients with unstable blood pressure (BP) and systolic BP 90 or 220 mmHg
- •3. Patients with ongoing symptomatic arrhthymia
- •4. Patients with contraindications to MRI including metallic implants
- •5 .Patients with any past sensitivity to iodinated contrast media will be eligible, but will not undergo CT perfusion or CT angiography
- •6. Patients deemed, as attending physician, unsuitable for RIC therapy due to local limb injury or bleeding risk
- •7. Patients who underwent thrombolysis and intra-arterial therapy will be eligible if the follow up CT scan at 36 hours has not demonstrated any parenchymal hematoma.
- •8. Patients with MRI demonstrated additional pathology including tumors or abscess. Individuals with small incidental lesions, at low risk of bleed such as meningiomas arteriovenous malformations and cavernomas maybe included at the discretion of the investigator
- •9. Pregnant and lactating women
- •10. Co-morbid illness with expected life expectancy less1 year.
- •11. Patients having stroke due to primary or secondary vasculitis syndrome
- •12. Patients with hereditary diseases like CADASIL, Fabryâ??s disease, Marfanâ??s syndrome, mitochondrial cytopathy
- •13. Patients with history of atherosclerotic or non-atherosclerotic peripheral vascular disease of upper limb, upper limb vascular bypass surgery or upper deep venous thrombosis.
- •14. Patients with history of systemic autoimmune disorder
- •15. Patients with easily bruising tendencies will be excluded, however patients on short-term or long-term anticoagulants will be included if they donâ??t bruise easily. Patients unlikely to be compliant with RIC therapy for 12 weeks
研究者
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