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临床试验/NCT02042547
NCT02042547已完成不适用

STUDY OF FACTORS FAVORING THE ONSET OF NOVO ATRIAL FIBRILLATION IN THE IMMEDIATE AFTERMATH OF CORONARY ARTERY BYPASS SURGERY

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Onset or a de novo episode of atrial fibrillation during the 7 days following heart surgery

研究概览

简要总结

Before la surgery:

Transthoracic cardiac echography will be done systematically, to measure among other things the size of the left atrium.

During surgery:

Surgery under extracorporeal circulation: tissue samples will be harvested from the right atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before declamping of the aorta (T1= post-ischemia sample).

Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG (T0) and a second sample after CABG (T1).

In parallel with the harvesting of cardiac tissue, blood samples will be taken at different times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the anesthetists.

After the surgery:

Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an observation notebook. The biological samples will be analysed immediately and the biological data obtained will be recorded in the observation notebook.

研究设计

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

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have provided written informed consent
  • Patients covered by the national health insurance scheme
  • Heart surgery (CABG) with and without extracorporeal circulation
  • Elective or deferred emergency surgery
  • Consecutive patients aged less than 80 years

排除标准

  • Patients less than 18, under guardianship
  • Patients over 18, under guardianship
  • Patients who do not understand the study data
  • Patients undergoing emergency surgery who therefore cannot be given or understand the explanations for the study (patients in shock, intubated patients with mechanical ventilation)
  • History of heart surgery
  • History of AF
  • Treatment with Cordarone.

结局指标

主要结局

Onset or a de novo episode of atrial fibrillation during the 7 days following heart surgery

时间窗: 7 days post-surgery

次要结局

  • Markers of ischemia: circulating Troponin I before the surgery and at the end of the procedure(Baseline and at the end of surgery (15 minutes after unclamping when extracorporeal circulation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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