Rotigaptide in Endothelial Dysfunction?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in forearm blood flow after ischaemia reperfusion with or without co-infusion of Rotigaptide
研究概览
简要总结
Arterial occlusion can lead to tissue ischemia and, if prolonged, end organ infarction. Clinical and experimental data would suggest that restoration of blood flow might trigger additional injury beyond that induced by the ischemia alone, so called Ischemia Reperfusion (IR) injury. IR injury impairs endothelial function through a mechanism that may involve intercellular gap junctions. Rotigaptide (ZP-123) is an anti-arrhythmic drug promoting intercellular coupling by increasing gap junction conductance. We intend to test the hypothesis that rotigaptide protects the forearm arterial circulation from IR-induced endothelial dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy males between 18-65 years of ages, non-smokers.
排除标准
- •Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.
研究组 & 干预措施
1
Ischaemia reperfusion (IR) injury (upper arm cuff inflated to 200 mmHg for 20 min) is induced during the study. Using bilateral forearm venous occlusion plethysmography, blood flow will be measured during intra-brachial infusion of acetylcholine (ACh; 5-20 µg/min) before and after IR injury and during intra-brachial co-infusion of saline-placebo
干预措施: Forearm vascular study (Procedure)
2
Ischaemia reperfusion (IR) injury (upper arm cuff inflated to 200 mmHg for 20 min) is induced during the study. Using bilateral forearm venous occlusion plethysmography, blood flow will be measured during intra-brachial infusion of acetylcholine (ACh; 5-20 µg/min) before and after IR injury and during intra-brachial co-infusion of rotigaptide
干预措施: Forearm vascular study (Procedure)
结局指标
主要结局
Change in forearm blood flow after ischaemia reperfusion with or without co-infusion of Rotigaptide
时间窗: 20 fixed timepoints throughout the study up to 4 hours
次要结局
未报告次要终点