Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
研究概览
简要总结
The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.
详细描述
We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age > 18
- •SAH from ruptured cerebral aneurysm within 48 hours of admission.
- •Modified Fisher grade 2,3,or 4
- •Planned surgical or endovascular aneurysm repair
排除标准
- •Pregnancy
- •SAH secondary to traumatic or mycotic aneurysms
- •Pre-ictal statin therapy
- •Contraindication to stain therapy
- •WFNS grade 5
- •Contraindications to MAP elevation on day 7-10
研究组 & 干预措施
Simvastatin, 80 mg/day
Simvastatin, 80 mg/day for 21 days
干预措施: Simvastatin, 80 mg/day for 21 days (Drug)
Placebo
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
时间窗: 7-10 days after hemorrhage
Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Cerebral Autoregulation During Peak Period of Vasospasm Risk
时间窗: 7-10 days after hemorrhage
Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) \* 100 A value of \<60 is considered abnormal.
次要结局
- Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk(7-10 days after hemorrhage)