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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Graft With or Without ECC
• Intervention / Treatment: Other: Blood samples; Other: Tissue samples from the right atrium

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU de Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Coronary artery bypass graft with or without extracorporeal circulation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients about to undergo heart surgery	Other: Blood samples; Other: Tissue samples from the right atrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Onset or a de novo episode of atrial fibrillation during the 7 days following heart surgery	7 days post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Estimate): January 23, 2014
• Last Update Submitted That Met QC Criteria: January 22, 2014
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LAURENT PARI 2010