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Completed

NCT Number: NCT02042547

Study Of Factors Favoring The Onset Of Novo Atrial Fibrillation In The Immediate Aftermath Of Coronary Artery Bypass Surgery

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.

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Key information

Conditions

Coronary Artery Bypass Graft With or Without ECC

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de DIJON

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Tissue samples from the right atrium

Other

Blood Samples

Other

Primary outcomes

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

    Time frame: 7 days post-surgery

Secondary outcomes

  1. Markers of ischemia: circulating Troponin I before the surgery and at the end of the procedure

    Time frame: Baseline and at the end of surgery (15 minutes after unclamping when extracorporeal circulation)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
First posted
Jan 23, 2014
Registry last updated
Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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