NCT03863158

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
476

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

12.2 years

First QC Date

March 1, 2019

Last Update Submit

March 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days

Secondary Outcomes (1)

  • Determine the predictors of intra-hospital mortality rate in hemodynamically stable patients operated of coronary bypass

    30 days

Interventions

No intervention / medical records only

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective Observationnal study (medical records only) on patients undergoing CABG in emergency from the 2007 January 1 to 2018 december 31.

You may qualify if:

  • Patients presenting acute myocardial infarction with hemodynamic stability at the diagnosis
  • Patients undergoing coronary artery bypass in Dijon University hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 5, 2019

Study Start

January 1, 2007

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

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.