Cardiac SurgeryNCT03863158
Optimal Timing of Coronary Artery Bypass Grafting in Hemodynamically Stable Patient After Myocardial Infarction and Definition of Poor Prognostic Factors. Pilot Study
An observational study of Cardiac Surgery, run by Centre Hospitalier La Chartreuse.
Trial summary
Acute coronary syndromes (ACS) represent the leading cause of death in France. Their incidence is increasing due to population aging and to the persistence of cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiac Surgery
- How many people
- 476 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 28 Feb 2019
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective Observationnal study (medical records only) on patients undergoing CABG in emergency from the 2007 January 1 to 2018 december 31.
Who may be able to join
- Patients presenting acute myocardial infarction with hemodynamic stability at the diagnosis
- Patients undergoing coronary artery bypass in Dijon University hospital
Who cannot join
- Patients with Acute pulmonary oedema
- Patients with cardiorespiratory arrest before coronary angiography
- hemodynamically unstable patient at diagnosis
- patients requiring combined surgery
- patients with unstable angina
About this study
Acute coronary syndromes (ACS) represent the leading cause of death in France. Their incidence is increasing due to population aging and to the persistence of cardiovascular risk factors. Currently, revascularization surgery remains outside the emergency treatment, because early performed, it tends to lead to extension and hemorrhage of the infarcted area, because of the CPB, aortic clamping, cardioplegia, and other heart manipulation.
However, CABG are indicated as an emergency in some situations of STEMI: Threat of infarction of an extended territory without favorable anatomy to angioplasty, anatomy not favorable to angioplasty associated with cardiogenic shock or persistent ischemia, acute complications of myocardial infarction (massive mitral insufficiency, interventricular communication, parietal rupture) requiring surgery under CPB with concomitant bypass surgery or failure of angioplasty (proximal coronary dissection).
Read more
Operative mortality is high; 15 to 20% for patients operated 12 to 48 hours after AMI and 4-5% for those operated after 48 hours.
Nevertheless, it seems legitimate to study if there would be a place for primary surgical revascularization in case of patient with hemodynamically stable ACS, in order to limit myocardial ischemia, spread of necrosis, to limit the risk of recurrence, and the consequences of low cardiac output. Performing a complete early surgical revascularization could limit the ischemia-reperfusion syndrome and anticipate the occurrence of cardiogenic shock.
Read the detailed description
Trial on medical records only
- Conditions
- Cardiac Surgery
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention / medical records only
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the mortality rate and the delay between the surgical revascularization and the date of diagnosis of mycardial infaction in hemodynamically stable patients
Delay in days between diagnosis and surgery
Measured: 30 days
Secondary outcomes (1)
Determine the predictors of intra-hospital mortality rate in hemodynamically stable patients operated of coronary bypass
Evaluate the results of evaluations carried out in patients who died compared to patients who did not die and the normal population
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jan 2007
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier La Chartreuse
- Sponsor type
- University, hospital or other
- Collaborators
- BOUCHOT Olivier, LAUBRIET-JAZAYERI Aline
- Responsible party
- Principal investigator, MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863158
- Sponsor's protocol ID
- CCVT-ChloéBernard 2019
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Screening of patients will be done from lists of patients who have undergone emergency coronary bypass surgery Demographic, clinical, paraclinical and biological data of patients will be collected internally using the data available in the computerized patient record of Dijon University Hospital (DxCare). The data will be collected in an Excel file, which is hosted by the CHU server. As this is a monocentric observational study, it is not envisaged that the data will be transferred outside Dijon University Hospital.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Coronary Artery Bypass Grafting in Hemodynamically Stable Patient After Myocardial Infarction and Definition of Poor Prognostic Factors. Pilot Study
- ClinicalTrials.gov ID
- NCT03863158
- Acronym / sponsor ID
- CCVT-ChloéBernard 2019
- Conditions
- Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Centre Hospitalier La ChartreuseUniversity, hospital or other
- Collaborators
- BOUCHOT Olivier, LAUBRIET-JAZAYERI Aline
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 5 Mar 2019 (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.
Acute coronary syndromes (ACS) represent the leading cause of death in France. Their incidence is increasing due to population aging and to the persistence of cardiovascular risk factors. Currently, revascularization surgery remains outside the emergency treatment, because early performed, it tends to lead to extension and hemorrhage of the infarcted area, because of the CPB, aortic clamping, cardioplegia, and other heart manipulation.
However, CABG are indicated as an emergency in some situations of STEMI: Threat of infarction of an extended territory without favorable anatomy to angioplasty, anatomy not favorable to angioplasty associated with cardiogenic shock or persistent ischemia, acute complications of myocardial infarction (massive mitral insufficiency, interventricular communication, parietal rupture) requiring surgery under CPB with concomitant bypass surgery or failure of angioplasty (proximal coronary dissection).
Operative mortality is high; 15 to 20% for patients operated 12 to 48 hours after AMI and 4-5% for those operated after 48 hours.
Nevertheless, it seems legitimate to study if there would be a place for primary surgical revascularization in case of patient with hemodynamically stable ACS, in order to limit myocardial ischemia, spread of necrosis, to limit the risk of recurrence, and the consequences of low cardiac output. Performing a complete early surgical revascularization could limit the ischemia-reperfusion syndrome and anticipate the occurrence of cardiogenic shock.
Detailed description
Trial on medical records only
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective Observationnal study (medical records only) on patients undergoing CABG in emergency from the 2007 January 1 to 2018 december 31.
Key inclusion criteria (2 listed)
- Patients presenting acute myocardial infarction with hemodynamic stability at the diagnosis
- Patients undergoing coronary artery bypass in Dijon University hospital
Key exclusion criteria (5 listed)
- Patients with Acute pulmonary oedema
- Patients with cardiorespiratory arrest before coronary angiography
- hemodynamically unstable patient at diagnosis
- patients requiring combined surgery
- patients with unstable angina
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 |
|---|---|---|
| No interventionNo intervention / medical records only | Other | – |
Primary outcome
Correlation between the mortality rate and the delay between the surgical revascularization and the date of diagnosis of mycardial infaction in hemodynamically stable patients
Time frame: 30 days
Delay in days between diagnosis and surgery
1 secondary outcome
Determine the predictors of intra-hospital mortality rate in hemodynamically stable patients operated of coronary bypass
Time frame: 30 days
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 5 Mar 2019.
- Individual participant dataSharing planned: No. Screening of patients will be done from lists of patients who have undergone emergency coronary bypass surgery Demographic, clinical, paraclinical and biological data of patients will be collected internally using the data available in the computerized patient record of Dijon University Hospital (DxCare). The data will be collected in an Excel file, which is hosted by the CHU server. As this is a monocentric observational study, it is not envisaged that the data will be transferred outside Dijon University Hospital.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Centre Hospitalier La Chartreuse.
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 2 inclusion and 5 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between the mortality rate and the delay between the surgical revascularization and the date of diagnosis of mycardial infaction in hemodynamically stable patients (time frame: 30 days). 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 5 Mar 2019.