Does recHDL Given i.v. Before CEA Prevent Cerebral Ischaemia? - the Reveal Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Inflammatory and thrombotic response
研究概览
简要总结
The plasma concentration of high-density lipoprotein (HDL) can have anti-inflammatory, anti-oxidative and anti-thrombotic effects in addition to being able to remove cholesterol from peripheral tissues for secretion via the liver.
The investigators hypothesise that elevation of plasma HDLs will reduce the inflammatory response following removal of unstable atherosclerotic plaques in the carotid artery. Such plaques can cause strokes and there is great benefit from early surgical removal, however such surgical procedures involve significant risks to the patient.
The investigators propose infusing HDL into patients prior to removal of their unstable carotid plaque and measuring the changes in inflammatory responses in comparison to a similar placebo controlled group of patients.
详细描述
Following written informed consent, patients will be randomised to either the placebo or active arm of the study. Bloods will be taken for baseline measurements, and the infusion of either saline (placebo) or rHDL (active agent) will be carried out on the ward. Infusion will take 4 hours, and the active agent infused at 40mg/kg.
Just prior to CAE, bloods will be collected (24 hours post-infusion) and the atherosclerotic tissue collected into RNA stabilising agent for subsequent analysis. Further bloods will then be collected 24 hours post-operatively (48 hours post-infusion).
Patients vital signs will be monitored hourly following infusion and will be reviewed in out-patients at 6 weeks after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients listed for elective carotid endarterectomy
排除标准
- •pregnant women and women of childbearing age
- •patient with impaired renal function or liver function
- •patients sectioned under the Mental Health Act
研究组 & 干预措施
1.Saline Infusion
Patients randomised to this arm will receive an infusion of saline
干预措施: Saline (Drug)
2.recHDL
Patients randomised to the active comparator arm of the study will receive 40mg/kg reconstituted High density lipoproteins (lot nos 05422-00006) over a period of 4 hours, 24 hours prior to carotid endarterectomy.
干预措施: Reconstituted High Density Lipoprotein (Drug)
结局指标
主要结局
Inflammatory and thrombotic response
时间窗: baseline, 24 hours after infusion, 48 hours after infusion
次要结局
未报告次要终点