Optimal Timing of Coronary Artery Bypass Grafting in Hemodynamically Stable Patient After Myocardial Infarction and Definition of Poor Prognostic Factors. Pilot Study

Cardiac Surgery Clinical Trial

Official title:

Optimal Timing of Coronary Artery Bypass Grafting in Hemodynamically Stable Patient After Myocardial Infarction and Definition of Poor Prognostic Factors. Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863158
• Other study ID #: CCVT-ChloéBernard 2019
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: Centre Hospitalier La Chartreuse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

Trial on medical records only

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients presenting acute myocardial infarction with hemodynamic stability at the diagnosis

• Patients undergoing coronary artery bypass in Dijon University hospital

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiac Surgery
• Infarction
• Myocardial Infarction

Intervention

Other:
• No intervention
No intervention / medical records only

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier La Chartreuse	BOUCHOT Olivier, LAUBRIET-JAZAYERI Aline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	30 days