The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)
研究概览
简要总结
The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).
详细描述
Background
Surgical and interventional therapy for aortic valve stenosis exposes the patients to a immune reaction, which is different depending on the type of the treatment. In this study, the investigators would like to better understand the inflammatory and antiinflammatory response in this patient population by monitoring the perioperative cytokine response (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma factors (CD62L) involved in inflammatory processes.
Objective
Characterisation of inflammatory and antiinflammatory response in patients receiving aortic valve prosthesis selected for different treatment options.
Methods
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Severe aortic valve stenosis
- •Surgical aortic valve replacement
- •Transcatheter aortic valve implantation
- •No previous inflammatory condition
- •Exclusion Criteria
- •Missing informed consent
- •Treatment with corticosteroids
- •Treatment with antibiotics
排除标准
- 未提供
结局指标
主要结局
Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)
时间窗: Perioperative period ending after 48 hours postoperatively
次要结局
- Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)(Perioperative period ending after 48 hours postoperatively)
- In-hospital mortality(In-hospital treatment until discharge (7-10 days))