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ALDOsterone for Prediction of Post-Operative Atrial Fibrillation (ALDO-POAF)

2016年6月27日 更新者：University Hospital, Caen

Post-operative atrial fibrillation (POAF) is a major and frequent complication occurring after cardiac surgery, contributing to prolonged intensive care and hospital stays and is associated with several cardiovascular complications. The exact mechanisms and signaling pathways involved in the development of POAF seem to be multifactorial and remain to date incompletely understood. β-blockers and amiodarone are the first line preventive drugs but are partially effective and near 30% of POAF resist to these strategies. In this context, there is some evidence indicating that renin-angiotensin-aldosterone system and Galectin-3 (Gal-3) share signaling pathways in the development of cardiac fibrosis and therefore could be very useful predictive biomarkers of POAF and potentially interesting therapeutic target to prevent POAF occurrence.

The investigators hypothesis is that preoperative plasma aldosterone levels and galectin-3 (Gal-3) expression (in plasma, right atrial appendage or epicardial fat) could be predictive of POAF in patients undergoing elective CABG surgery with preserved LVEF.

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
    • Basse Normandie
      • Caen、Basse Normandie、法国、14000

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

The ALDO-POAF study is an observational, 1-center and prospective pilot study that will enroll patients undergoing CABG ± aortic valve replacement. Patients who had emergency CABG, need for concomitant mitral surgery, left ventricular ejection fraction (LVEF) < 50%, a history of AF or other atrial arrhythmia, unstable angina or heart failure, cardiogenic shock, atrioventricular block, hypothyroidism/hyperthyroidism, previous heart surgery, and off-pump or on-pump beating CABG will be excluded. Approval for this study, including collection of human tissues (right atrial appendage, subcutaneous and epicardial fat) and blood collection, was obtained from the Ethics Committee of Caen University Hospital (Comité de Protection des Personnes Nord-Ouest III, Caen, France) and will be in accordance to the declaration of Helsinki; the details of the study will be explained to the subjects, and written informed consent will be obtained from each patient.

描述

Inclusion Criteria:

  • Patients hospitalized for planned surgical coronary revascularization +/- aortic replacement valve
  • Aged 18 years at least
  • Clinically Stable (see criteria for non-inclusion)
  • With left ventricular ejection fraction preserved (>50%)

Exclusion Criteria:

  • Patient having already AF history
  • Patient with primary hyperaldosteronism
  • Unstable Patient defined as any cardiovascular event occurred in the previous 30 days

These events are:

  • hospitalisation for cardiovascular causes
  • appearance or worsening of symptoms consistent with cardiac failure
  • appearance or worsening symptoms of coronary
  • Patient refusing participation in the study
  • Patient unable to provide follow-up visits
  • need for concomitant mitral surgery
  • Emergency CABG
  • Left ventricular ejection fraction (LVEF) < 50%
  • Previous heart surgery
  • Off pump CABG.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Planned cardiac surgery. POAF occurence or not
The ALDO-POAF study is an observational, 1-center and prospective pilot study that will enroll patients undergoing CABG ± aortic valve replacement. Patients who had emergency CABG, need for concomitant mitral surgery, left ventricular ejection fraction (LVEF) < 50%, a history of AF or other atrial arrhythmia, unstable angina or heart failure, cardiogenic shock, atrioventricular block, hypothyroidism/hyperthyroidism, previous heart surgery, and off-pump or on-pump beating CABG will be excluded.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Occurrence of atrial fibrillation in post-operative period of cardiac surgery (CABG +/- aortic valve replacement)
大体时间：1 month
1 month

次要结果测量

结果测量
大体时间
Find a correlation between the local secretion of aldosterone by adipocytes epicardial and the occurrence of AF during the 6 months after surgery in patients undergoing cold bypass coronary artery.
大体时间：6 months
6 months
Find a correlation between aldosterone levels secreted in epicardial adipocytes and plasma aldosterone levels.
大体时间：1 month
1 month
Find a correlation between preoperative plamastic aldosterone levels and occurence of postoperative atrial fibrillation
大体时间：1 month
1 month
Detect aldosterone synthase aldosterone or angiotensin II (measured by quantitative and qualitative assays Western Blot, mRNA or RT-PCR) in the epicardial fat removed during surgery in patients undergoing a CABG.
大体时间：1 month
1 month
Find a correlation between preoperative plamastic galectin-3 levels and occurrence of postoperative atrial fibrillation
大体时间：1 month
1 month
Find a correlation between preoperative plamastic ngal levels and occurrence of postoperative atrial fibrillation
大体时间：1 month
1 month
Find a correlation between preoperative mitochondrial function and occurrence of postoperative atrial fibrillation
大体时间：1 month
1 month
Find a correlation between preoperative left atrial strain and occurrence of postoperative atrial fibrillation
大体时间：1 month
1 month
Find a correlation between acute renal failure and occurrence of postoperative atrial fibrillation
大体时间：1 month
1 month
Find a correlation between occurrence of postoperative atrial fibrillation and all cause cardiovascular morbimortality
大体时间：2 years
2 years
Find a correlation between occurrence of postoperative atrial fibrillation and length of hospitalisation
大体时间：1 month
1 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Caen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年1月1日

初级完成 (预期的)

2017年6月1日

研究完成 (预期的)

2017年8月1日

研究注册日期

首次提交

2016年6月14日

首先提交符合 QC 标准的

2016年6月27日

首次发布 (估计)

2016年6月28日

研究记录更新

最后更新发布 (估计)

2016年6月28日

上次提交的符合 QC 标准的更新

2016年6月27日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A14-D05-VOL.20

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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