Bypass Graft StenosisNCT06181565
The Impact of Pericardial Closure on the Grafts, in the Context of Coronary Artery Bypass Grafting
An observational study of Bypass Graft Stenosis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Once the pericardium is closed, there is no information on the hemodynamics of the grafts after coronary artery bypass grafting. This would be the reason for different opinions on pericardial closure: some teams do not close the pericardium and others close it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bypass Graft Stenosis
- What is being tested?
- Datas of Medistim machine
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 24 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who will have isolated aortocoronary bypass grafting surgery will be included.
Who may be able to join
- All patients who will have isolated aortocoronary bypass grafting surgery
Who cannot join
- History of thoracic trauma
- Severe cyphosis
- Severe thoracic deformity (Pectus excavatum)
- Pericardial disease
- History of radiotherapy
- Severe pulmonary disease (emphysema)
- Right heart failure
- Redo surgery
Trial locations and contacts
1 site in 1 country.
About this study
Once the pericardium is closed, there is no information on the hemodynamics of the grafts after coronary artery bypass grafting. This would be the reason for different opinions on pericardial closure: some teams do not close the pericardium and others close it.
In the department Cardiovascular Surgery of the University Hospital of Saint-Etienne, the Medistim machine is used in routine and the hemodynamic properties of the grafts are recorded immediately after the bypass surgery, before the closure of the pericardium.
Read the detailed description
The aim of the study is to have hemodynamic information immediately after the closure of the pericardium using the Medistim machine. The prospective study will be conducted on 50 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.
- Conditions
- Bypass Graft Stenosis
- Being tested
- Datas of Medistim machine
- Keywords
- Cardiac surgery, pericardial closure, grafts, bypass, aortocoronary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Datas of Medistim machineOther
Also called Medistim machine
Datas will be collected by Medistim machine before and after pericardial closure: Flow through the grafts, Resistance on grafts, Pulsatility of the grafts, Systolic and diastolic curves before and after pericardial closure
| Study group | Role | What they receive |
|---|---|---|
| Patients who will have isolated aortocoronary bypass grafting surgery | Patients who will have isolated aortocoronary bypass grafting surgery will be included.
The Medistim machine will be use before and after pericardial closure. Datas will be collected and analysis. Receives: Other: Datas of Medistim machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow through the grafts
Datas will be collected by Medistim machine.
Measured: Minute : 1, 15
Secondary outcomes (4)
Resistance on grafts
Datas will be collected by Medistim machine.
Measured: Minute : 1, 15
Pulsatility of the grafts
Datas will be collected by Medistim machine.
Measured: Minute : 1, 15
Systolic curves
Datas will be collected by Medistim machine.
Measured: Minute : 1, 15
Diastolic curves
Datas will be collected by Medistim machine.
Measured: Minute : 1, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jan 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bypass Graft StenosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andranik PETROSYAN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181565
- Sponsor's protocol ID
- IRBN1342021/CHUSTE
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pericardial Closure on the Grafts, in the Context of Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT06181565
- Acronym / sponsor ID
- IRBN1342021/CHUSTE
- Conditions
- Bypass Graft Stenosis
- Keywords
- Cardiac surgery, pericardial closure, grafts, bypass, aortocoronary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 26 Dec 2023 (actual)
- 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.
Once the pericardium is closed, there is no information on the hemodynamics of the grafts after coronary artery bypass grafting. This would be the reason for different opinions on pericardial closure: some teams do not close the pericardium and others close it.
In the department Cardiovascular Surgery of the University Hospital of Saint-Etienne, the Medistim machine is used in routine and the hemodynamic properties of the grafts are recorded immediately after the bypass surgery, before the closure of the pericardium.
Detailed description
The aim of the study is to have hemodynamic information immediately after the closure of the pericardium using the Medistim machine. The prospective study will be conducted on 50 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who will have isolated aortocoronary bypass grafting surgery | – | Other: Datas of Medistim machinePatients who will have isolated aortocoronary bypass grafting surgery will be included. The Medistim machine will be use before and after pericardial closure. Datas will be collected and analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who will have isolated aortocoronary bypass grafting surgery will be included.
Key inclusion criteria (1 listed)
- All patients who will have isolated aortocoronary bypass grafting surgery
Key exclusion criteria (8 listed)
- History of thoracic trauma
- Severe cyphosis
- Severe thoracic deformity (Pectus excavatum)
- Pericardial disease
- History of radiotherapy
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 |
|---|---|---|
| Datas of Medistim machineAlso: Medistim machineDatas will be collected by Medistim machine before and after pericardial closure: Flow through the grafts, Resistance on grafts, Pulsatility of the grafts, Systolic and diastolic curves before and after pericardial closure | Other | Patients who will have isolated aortocoronary bypass grafting surgery |
Primary outcome
Flow through the grafts
Time frame: Minute : 1, 15
Datas will be collected by Medistim machine.
4 secondary outcomes
Resistance on grafts
Time frame: Minute : 1, 15
Pulsatility of the grafts
Time frame: Minute : 1, 15
Systolic curves
Time frame: Minute : 1, 15
Diastolic curves
Time frame: Minute : 1, 15
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 26 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Bypass Graft Stenosis
Not yet recruitingObservational study
Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
Coronary Bypass Graft Stenosis, Valvular Heart Disease
Active, not recruitingObservational study
Registry of Secondary Revascularization
Coronary Artery Disease Progression, Coronary Artery Disease of Significant Bypass Graft
Recruiting
Myocardialbridge Bypass Graft Surgery Efficacy Verification
Myocardial Bridge of Coronary Artery, Myocardial Bridge
Not yet recruitingObservational study
Transit Time Flow Measurement in Coronary Surgery
Coronary Artery Disease, Coronary Stenosis
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.
Andranik PETROSYAN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Bypass Graft Stenosis, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 8 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 26 Dec 2023. 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?
Flow through the grafts (time frame: Minute : 1, 15). 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 26 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.