Coronary Artery Bypass Graft With or Without ECCNCT02042547
Study Of Factors Favoring The Onset Of Novo Atrial Fibrillation In The Immediate Aftermath Of Coronary Artery Bypass Surgery
An observational study of Coronary Artery Bypass Graft With or Without ECC, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Coronary Artery Bypass Graft With or Without ECC
- What is being tested?
- Tissue samples from the right atrium and Blood samples
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Coronary artery bypass graft with or without extracorporeal circulation
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Tissue samples from the right atrium, Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue samples from the right atriumOther
Blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients about to undergo heart surgery | Not described Receives: Other: Tissue samples from the right atrium; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset or a de novo episode of atrial fibrillation during the 7 days following heart surgery
Measured: 7 days post-surgery
Secondary outcomes (1)
Markers of ischemia: circulating Troponin I before the surgery and at the end of the procedure
Measured: Baseline and at the end of surgery (15 minutes after unclamping when extracorporeal circulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startSep 2010
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft With or Without ECCStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042547
- Sponsor's protocol ID
- LAURENT PARI 2010
- Status last verified
- Nov 2010
- First submitted
- 17 Jan 2014
- Last updated
- 23 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY OF FACTORS FAVORING THE ONSET OF NOVO ATRIAL FIBRILLATION IN THE IMMEDIATE AFTERMATH OF CORONARY ARTERY BYPASS SURGERY
- ClinicalTrials.gov ID
- NCT02042547
- Acronym / sponsor ID
- LAURENT PARI 2010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients about to undergo heart surgery | – | Other: Tissue samples from the right atrium, Other: Blood samples |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary artery bypass graft with or without extracorporeal circulation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue samples from the right atrium | Other | Patients about to undergo heart surgery |
| Blood samples | Other | Patients about to undergo heart surgery |
Primary outcome
Onset or a de novo episode of atrial fibrillation during the 7 days following heart surgery
Time frame: 7 days post-surgery
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
Related trials for Coronary Artery Bypass Graft With or Without ECC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Graft With or Without ECC, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset or a de novo episode of atrial fibrillation during the 7 days following heart surgery (time frame: 7 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.