Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Difference in microparticle levels
研究概览
简要总结
Microparticles are small cell fragments that can induce fat plaques, calcification and formation of thrombus. They can be released through multiple stimulations, but also the high flow of blood through partially obstructed aortic valves.
In patients with severely obstructed aortic valves the investigators hypothesize that microparticles levels will be elevated and that they will go down after percutaneous treatment of the valves.
详细描述
Microparticle (MPs) levels and subtypes according to endothelial cell, macrophage and platelet markers will be measured by flow-cytometry using appropriate fluorochromes. Patient baseline (including measures of severity of aortic stenosis and its calcification), procedural data, and clinical evolution will be collected. Inflammatory markers will be measured, which along with clinical date will be tested for correlation with microparticle levels.
Patients MPs will be measured before and after percutaneous treatment of the severe aortic stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Clinical indication to be treated with transcatheter aortic valve replacement.
排除标准
- •Non native aortic valve
- •Moderate aortic regurgitation
- •The following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.
结局指标
主要结局
Difference in microparticle levels
时间窗: Day 5
Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement
次要结局
- Endothelial microparticle levels(Day 5)
- Macrophage microparticle levels(Day 5)
- Platelet microparticle levels(Day 5)
研究者
Pedro A. Lemos
Professor of Medicine
InCor Heart Institute