跳至主要内容
临床试验/NCT03135496
NCT03135496已完成不适用

Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Analysis of the variation of the following endothelial function markers: angiopoetin 1 and 2 depending on whether or not extracorporeal circulation

研究概览

简要总结

Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach.

To date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.

Two recent studies have demonstrated a sustained improvement in endothelial function with TAVI. On the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (CEC) could be the result of the interaction between pre-existing endothelial dysfunction And the "operative" aggression associated with the CEC.

Thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to CEC. This phenomenon would not exist in TAVI, and would explain the absence of so-called vascular dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • •Patient ≥ 18 years.
  • •Patient operated on aortic valvular replacement by bioprosthesis in surgery + CEC or TAVI
  • •Signed consent.
  • •Affiliation to Social Security

排除标准

  • •Any other cardiac surgery
  • •Mechanical aortic valve replacement
  • •Permanent Ac / Fa.
  • •Pregnant woman.
  • •Curative anticoagulation (AVK, NANCO, heparin).
  • •Patient under tutelage or curatelle.
  • •Refusal of the patient.
  • •Participation in another study.
  • •Preoperative sepsis
  • •Minor or adult, under guardianship or curatorship

结局指标

主要结局

Analysis of the variation of the following endothelial function markers: angiopoetin 1 and 2 depending on whether or not extracorporeal circulation

时间窗: 1 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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