Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 1:43 PM
Study NCT ID:
NCT03863158
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2019-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Timing of Coronary Artery Bypass Grafting in Hemodynamically Stable Patient After Myocardial Infarction and Definition of Poor Prognostic Factors. Pilot Study
Sponsor:
Centre Hospitalier La Chartreuse
Organization:
Study Overview
Official Title:
Optimal Timing of Coronary Artery Bypass Grafting in Hemodynamically Stable Patient After Myocardial Infarction and Definition of Poor Prognostic Factors. Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: