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

NCT02042547 | Completed

• 1 other identifier: LAURENT PARI 2010
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Bypass Graft With or Without ECC

Outcome Measures

Primary Outcomes (1)

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

  7 days post-surgery

Secondary Outcomes (1)

• 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)

Study Arms (1)

Patients about to undergo heart surgery

Other: Tissue samples from the right atrium; Other: Blood samples

Interventions

Tissue samples from the right atrium OTHER

Patients about to undergo heart surgery

Blood samples OTHER

Patients about to undergo heart surgery

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Coronary artery bypass graft with or without extracorporeal circulation

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 23, 2014
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Last Updated: January 23, 2014

Record last verified: 2010-11

Locations

FR (1)