RecruitingNot ApplicableNCT04184635

Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock

Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

400 participants

Start Date

Oct 14, 2021

Study Type

INTERVENTIONAL

Conditions

Cardiogenic Shock Acute Myocardial Infarction

Summary

Data from case series and large retrospective trials suggest that the early treatment of cardiogenic shock AMI patients with the association of VA-ECMO and IABP may significantly decrease mortality, which is still unacceptably high nowadays (40-50% at 30 days). An important benefit for the patients randomized to the ECMO arm is expected and the risk-to-benefit ratio is expected to be in favor of the experimental treatment arm.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI)
Revascularization by PCI for acute myocardial infarction has been performed or is planned in the following 60 minutes
Systolic blood pressure \<90 mmHg for \>30 min or catecholamine support required to maintain systolic blood pressure \>90 mmHg
Signs of pulmonary congestion
Signs of impaired organ perfusion with at least one of the following:
Altered mental status OR cold, clammy skin and extremities OR oliguria with urine output \<30 ml/h OR serum lactate \>2.0 mmol/l

Exclusion Criteria16

Age \<18 years
Pregnancy
Onset of shock \>24 Hours
Shock of other cause (hypovolemic, anaphylactic or vagal shock)
Shock due to massive pulmonary embolism
Resuscitation \>30 minutes
No intrinsic heart activity
Patient moribund on the day of randomization or SAPS II \>90
Surgical revascularization for AMI (CABG) planned or already performed prior to randomization
Cerebral deficit with fixed dilated pupils or Irreversible neurological pathology
Mechanical infarction complication (massive mitral regurgitation, pericardium drainage required, septal ventricular defect)
Severe peripheral artery disease or previous aortic or ilio-femoral surgery precluding ECMO and IABP insertion
Aortic regurgitation \> II
Other severe concomitant disease with limited life expectancy \< 1 year
Proven heparin-induced thrombocytopenia
ECMO device not immediately available

Interventions

DEVICEVA-ECMO

* The ECMO device will be the CardioHelp (MAQUET, GETINGE, Orléans, France) using the veno-arterial setting and percutaneous femoro-femoral cannulation with MAQUET GETINGE HLS cannulae. * Intraortic balloon pump will be MEGA 50 cc or 40cc, (MAQUET, GETINGE, Orléans, France).