Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock

NCT04184635 | Recruiting DMC

• 2 other identifiers: P140936N°ID-RCB : 2019-A00275-52
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction; Cardiogenic Shock

Keywords

cardiogenic shock; VA-ECMO; STEMI; NSTEMI; Intraortic balloon pump

Outcome Measures

Primary Outcomes (1)

• Treatment failure at Day 30

  Death in the ECMO group and death OR rescue ECMO in the control group

  At day 30

Secondary Outcomes (32)

• Mortality at Day 30

  At day 30

• Major Adverse Cardiovascular Events

  At day 30

• Stroke

  At day 30

• Recurrent myocardial infarction

  At day 30

• Need for repeat revascularization with PCI and/or CABG

  At day 30

Study Arms (2)

Experimental ECMO + IABP Arm

EXPERIMENTAL

VA-ECMO will be instituted percutaneously under echo guidance via the femoral route as soon as possible. An IABP will be systematically inserted in the contralateral femoral artery (unless technically not possible).

Device: VA-ECMO

Control Conventional Treatment Arm

NO INTERVENTION

Standard management of cardiogenic shock due to myocardial infarction according to the current ESC guidelines. It is not recommended to use IABP support and no other TCS device (e.g., ECMO, Impella, Thoratec PHP, TandemHeart) will be permitted in the control group.

Interventions

VA-ECMO DEVICE

* 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).

Experimental ECMO + IABP Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpétrière

Paris, 75013, France

RECRUITING

Related Publications (5)

• Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.

  PMID: 29083953 BACKGROUND

• Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

  PMID: 25173339 BACKGROUND

• Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Fuernau G, Eitel I, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Jobs A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Hunziker L, Savonitto S, Torremante P, Vrints C, Schneider S, Zeymer U, Desch S; CULPRIT-SHOCK Investigators. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710. doi: 10.1056/NEJMoa1808788. Epub 2018 Aug 25.

  PMID: 30145971 BACKGROUND

• Overtchouk P, Pascal J, Lebreton G, Hulot JS, Luyt CE, Combes A, Kerneis M, Silvain J, Barthelemy O, Leprince P, Brechot N, Montalescot G, Collet JP. Outcome after revascularisation of acute myocardial infarction with cardiogenic shock on extracorporeal life support. EuroIntervention. 2018 Apr 6;13(18):e2160-e2168. doi: 10.4244/EIJ-D-17-01014.

  PMID: 29400656 BACKGROUND

• Muller G, Flecher E, Lebreton G, Luyt CE, Trouillet JL, Brechot N, Schmidt M, Mastroianni C, Chastre J, Leprince P, Anselmi A, Combes A. The ENCOURAGE mortality risk score and analysis of long-term outcomes after VA-ECMO for acute myocardial infarction with cardiogenic shock. Intensive Care Med. 2016 Mar;42(3):370-378. doi: 10.1007/s00134-016-4223-9. Epub 2016 Jan 29.

  PMID: 26825953 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Alain COMBES, MD, PhD

  Centre Hospitalier Universitaire Pitié-Salpêtrière Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain COMBES, MD, PhD

CONTACT

01.42.16.38.16; alain.combes@aphp.fr

Gilles MONTALESCOT, MD, PhD

CONTACT

01.42.16.30.07; gilles.montalescot@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, randomized, comparative open trial will be conducted on two parallel groups of patients with AMI complicated by cardiogenic shock.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: October 14, 2021
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 14, 2027
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)