Coronary Artery Bypass Graft With or Without ECC Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 79 Years |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de DIJON | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Onset or a de novo episode of atrial fibrillation during the 7 days following heart surgery | 7 days post-surgery | No | |
| Secondary | 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) | No |