Safety and Efficacy of Remote Ischemic Conditioning in Patients With Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage:A Multicenter, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
Cerebral amyloid angiopathy-related intracerebral (CAAH) hemorrhage is second factor of primary intracerebral hemorrhage. However, no effective prevention and treatment strategies have been established. Remote ischemic conditioning is a neuroprotective strategy. In animal studies，RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
详细描述
In China, primary intracerebral hemorrhage accounts for 80-85% of all types of intracerebral hemorrhage, while cerebral amyloid angiopathy-related intracerebral hemorrhage is the second factor, accounting for approximately 20-30%. It is often characterized by repeated and multifocal lobar hemorrhage, which will not only cause neurological deficit on the limbs, but also influence the cognitive level of patients and may even be life-threatening. At present, the role of surgery in CAA-related ICH is controversial, and there is no effective prevention and treatment strategies have been established. Additionally, it is always associated with a low rate of good prognosis(11%-60%) and a high risk of recurrent ICH (10%-60%). Thus, a novel approach which can improve the clinical outcome and reduce the risk of recurrent intracerebral hemorrhage is urgently needed.
Remote ischemic conditioning (RIC) has been developed as a neuroprotective strategy to prevent and treat acute ischemic stroke and small cerebrovascular disease. Additionally, clinical research testified that RIC is safe and feasible for patients with subarachnoid hemorrhage. In animal studies, RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥55 and ≤
- •The diagnosis of single or multiple spontaneous lobar cerebral hemorrhage is confirmed by brain CT scan(defined as possible or probable CAA by the Boston criteria) .
- •Hematoma volume of 10 to 50 ml.
- •Glasgow Coma Score (GCS)>
- •Without surgery.
- •Starting RIC treatment between 24 and 48 hours of ictus.
- •Signed and dated informed consented is obtained.
排除标准
- •Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis.
- •ICH concomitant with intraventricular hemorrhage, subdural hematoma, epidural hematoma subarachnoid hemorrhage or the condition of unstable vital signs which may be life-threatening.
- •Evidence of significant shift of midline brain structure (>5mm) or herniation on brain imaging.
- •Contraindication to MRI scan, such as intracranial metal implants, cardiac pacemaker, severe claustrophobia, history of seizures and so on
- •Patients with a pre-existing neurological deficits (modified Ranks scale score >2) or psychiatric disease that would confound the neurological or functional evaluations.
- •Use of warfarin or heparin within 7 days before the baseline visit
- •Contraindication for remote ischemic conditioning: severe soft tissue injury, limb deformities, fracture, atrial fibrillation or peripheral vascular disease in the upper limbs.
- •Life expectancy of less than 1 year due to co-morbid conditions.
- •Severe, sustained hypertension (SBP > 180 mmHg or DBP > 110 mmHg).
- •Severe hepatic and renal dysfunction.
- •Known pregnancy (or positive pregnancy test), or breast-feeding.
- •Concurrent participation in another research protocol for investigation of another experimental therapy.
- •Any condition which, in the judgment of the investigator, might increase the risk to the patient.
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 90±7 days
Safety
次要结局
- Changes of perihematomal edema volume(14± 2 days)
- Shift of midline brain structure(14± 2 days)
- Changes of intracerebral hematoma volume(14± 2 days)
- Incidence rate of the perihematomal edema expansion(14± 2 days)
- Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases，MMPs)(7± 2 days)
- Changes of serum biomarker of inflammatory ( interleukin)(7± 2 days)
- Other adverse events related to RIC treatment(90±7 days)
- Prognosis of neurological function at 90 Days(90±7 days)
- Prognosis of function outcome at 90 Days(90±7 days)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University