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Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock (ANCHOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04184635
Recruitment Status : Suspended (problem with the device (dilatator of the introducer) used to introduce the intra arterial balloon)
First Posted : December 3, 2019
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Cardiogenic Shock Device: VA-ECMO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multicenter, prospective, randomized, comparative open trial will be conducted on two parallel groups of patients with AMI complicated by cardiogenic shock.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)
Actual Study Start Date : October 14, 2021
Estimated Primary Completion Date : October 14, 2024
Estimated Study Completion Date : October 14, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arm Intervention/treatment
Experimental: Experimental ECMO + IABP Arm

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
  • 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).

No Intervention: Control Conventional Treatment Arm
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.



Primary Outcome Measures :
  1. Treatment failure at Day 30 [ Time Frame: At day 30 ]
    Death in the ECMO group and death OR rescue ECMO in the control group


Secondary Outcome Measures :
  1. Mortality at Day 30 [ Time Frame: At day 30 ]
    All-cause mortality at day 30

  2. Major Adverse Cardiovascular Events [ Time Frame: At day 30 ]
    Major Adverse Cardiovascular Events are defined as death, stroke (any new neurological symptoms in association with signs of ischemia or hemorrhage in a cranial CT or MRI), recurrent myocardial infarction, need for repeat revascularization (PCI and/or CABG), renal replacement therapy, re-hospitalization for heart failure, escalation to permanent left ventricular assist device (LVAD) or total artificial heart, cardiac transplant.

  3. Stroke [ Time Frame: At day 30 ]
    Any new neurological symptoms in association with signs of ischemia or hemorrhage in a cranial CT or MRI

  4. Recurrent myocardial infarction [ Time Frame: At day 30 ]
    Recurrent myocardial infarction

  5. Need for repeat revascularization with PCI and/or CABG [ Time Frame: At day 30 ]
    Need for repeat revascularization (PCI and/or CABG)

  6. Need for renal replacement therapy [ Time Frame: At day 30 ]
    Need for renal replacement therapy

  7. Re-hospitalization for heart failure [ Time Frame: At day 30 ]
    re-hospitalization for heart failure

  8. Escalation to LVAD or total artificial heart [ Time Frame: At day 30 ]
    Escalation to permanent left ventricular assist device or total artificial heart

  9. Cardiac transplantation [ Time Frame: At day 30 ]
    Cardiac transplantation

  10. Major bleeding [ Time Frame: At day 30 ]
    Major bleeding (TIMI definition): Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI) OR Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in hematocrit OR Fatal bleeding (bleeding that directly results in death within 7 d)

  11. Red blood cells transfused [ Time Frame: At day 30 ]
    Number of packed red blood cells transfused

  12. Serum lactate [ Time Frame: At day 30 ]
    Time to serum lactate normalization

  13. Number of days alive without organ failure at day 30 [ Time Frame: At day 30 ]
    Number of days alive without organ failure(s) defined with the SOFA score, catecholamine support, mechanical ventilation and renal replacement therapy

  14. Durations of ICU stay and hospitalization [ Time Frame: At day 30 ]
    Durations of ICU stay and of hospitalization

  15. LV function [ Time Frame: At day 30 ]
    LV function assessed with Doppler echocardiography or magnetic resonance imaging

  16. NYHA/INTERMACS status [ Time Frame: At day 30 ]
    NYHA/INTERMACS status

  17. ECMO-related complications [ Time Frame: At day 30 ]
    ECMO-related complications (infection at VA-ECMO cannulation sites requiring antibiotics, hemorrhage, limb ischemia requiring surgery, cannula or circuit thrombosis, overt pulmonary edema, thrombocytopenia, gaseous emboli and hemolysis).

  18. Treatment failure at one year [ Time Frame: At one year ]
    Treatment failure defined as death (all-cause) in the ECMO group and death (all-cause) OR rescue ECMO in the control group.

  19. Mortality at one year [ Time Frame: At one year ]
    All-cause mortality

  20. Major Adverse Cardiovascular at one year [ Time Frame: At one year ]
    MACE, Major Adverse Cardiovascular Events are defined as death, stroke (any new neurological symptoms in association with signs of ischemia or hemorrhage in a cranial CT or MRI), recurrent myocardial infarction, need for repeat revascularization (PCI and/or CABG), renal replacement therapy, re-hospitalization for heart failure, escalation to permanent left ventricular assist device (LVAD) or total artificial heart, cardiac transplant.

  21. Stroke at one year [ Time Frame: At one year ]
    Stroke (any new neurological symptoms in association with signs of ischemia or hemorrhage in a cranial CT or MRI),

  22. Recurrent myocardial infarction at one year [ Time Frame: At one year ]
    Recurrent myocardial infarction between randomization and one year

  23. PCI and/or CABG at one year [ Time Frame: At one year ]
    Repeat revascularization (PCI and/or CABG) between randomization and one year

  24. Renal replacement therapy at one year [ Time Frame: At one year ]
    Need for renal replacement therapy between randomization and one year

  25. Re-hospitalization for heart failure [ Time Frame: At one year ]
    Re-hospitalization for heart failure between randomization and one year

  26. LVAD at one year [ Time Frame: At one year ]
    Escalation to permanent left ventricular assist device (LVAD) or total artificial heart

  27. Cardiac transplant at one year [ Time Frame: At one year ]
    Cardiac transplantation

  28. Major bleeding at one year [ Time Frame: At one year ]
    Major bleeding (TIMI definition): Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI) OR Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in hematocrit OR Fatal bleeding (bleeding that directly results in death within 7 d)

  29. NYHA/INTERMACS status at one year [ Time Frame: At one year ]
    NYHA/INTERMACS status

  30. Returned to work at one year [ Time Frame: At one year ]
    Rate of patients who returned to work if previously active

  31. LV ejection fraction at one year [ Time Frame: At one year ]
    Latest LV ejection fraction

  32. Short Form 36 (SF-36) questionnaire at one year [ Time Frame: At one year ]
    Quality of life assessed using the Short Form 36 (SF-36) Health Survey questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184635


Locations
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France
Hôpital Pitié Salpétrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Alain COMBES, MD, PhD Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04184635    
Other Study ID Numbers: P140936
N°ID-RCB : 2019-A00275-52 ( Other Identifier: ANSM )
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
cardiogenic shock
VA-ECMO
STEMI
NSTEMI
Intraortic balloon pump
Additional relevant MeSH terms:
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Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases