Acute Myocardial InfarctionANCHORNCT04184635
Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock
A study testing VA-ECMO in people with Acute Myocardial Infarction and Cardiogenic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Cardiogenic Shock
- What is being tested?
- VA-ECMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2021to 14 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pitié Salpétrière
Paris, 75013
ALAIN COMBES, MD, 01 42 16 38 18, alain.combes@aphp.fr
About this study
Official title: Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)
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.
Read the detailed description
Scientific background
- Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used more and more frequently in patients with acute myocardial infarction (AMI) and refractory cardiogenic shock despite the absence of high level scientific evidence to recommend the use of temporary circulatory support devices (TCS) in this setting.TCS support may also benefit to cardiogenic shock patients not initially refractory to conventional medical management since their mortality exceeds 40% and most of deaths are due to the development of refractory cardiogenic shock and multiple organ failure.
The ANCHOR trial is therefore designed to test the hypothesis that VA-ECMO support associated with IABP results in improved outcomes in comparison with optimal medical treatment alone in patients with AMI and cardiogenic shock. An ethical rescue option to VA-ECMO will however be provided to control patients with cardiogenic shock refractory to conventional medical treatment since recent data suggested survival up-to 50% with ECMO support in this setting.
Main objective - To determine if early VA-ECMO combined with IABP support and optimal medical treatment would improve the outcomes of patients with acute myocardial infarction complicated by cardiogenic shock as compared with optimal medical treatment alone.
Scope of the study
- Patients satisfying all of the Inclusion and Exclusion Criteria will be classified as 'Eligible'. Consent to research will be obtained from a close relative or surrogate for all eligible patients prior to randomization.
Should such a person be absent, eligible patients will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
Randomization will be possible in centers with robust experience in the management of AMI and cardiogenic shock but no on-site ECMO capability providing that an ECMO retrieval team from the nearest ECMO center can establish ECMO no later than 2 hours after randomization.
Before randomization, physicians at the non-ECMO center will check that the ECMO team is immediately available and that an ICU/CCU bed is available at the ECMO center. Thereafter, if the patient is randomized to the ECMO arm, the mobile ECMO retrieval team will travel to the center, initiate VA-ECMO and will rapidly transfer the patient on VA-ECMO to the ECMO center.
Description of experimental ECMO + IABP Arm
- Protocolized conventional management of cardiogenic shock
- VA-ECMO will be started as soon as possible
- For patients randomized at non-ECMO centers, a mobile ECMO team will initiate ECMO at the non-ECMO center and transport the patient to the ECMO center immediately
- IABP inserted in the contralateral femoral artery (unless technically not possible)
- ECMO management according to protocol
- ECMO weaning according to protocol
Description of conventional treatment Arm
- Protocolized conventional management of cardiogenic shock
- IABP not recommended. No other TCS device (e.g., ECMO, Impella, Thoratec PHP, TandemHeart) permitted
- Rescue VA-ECMO only if one of 1 or 2 or 3 applies:
- 1. Refractory cardiogenic shock defined as
- Cardiac index <1.2 l/min/m² or VTI <6 cm AND
- Assessment and correction of hypovolemia AND
- (dobutamine ≥15 microg/kg/min + norepinephrine ≥1.5 microg/kg/min) OR epinephrine ≥ 0.75 microg/kg/min
- Serum lactate >5 mmol/L or serum lactate increased >50% in the last 6 hours
- 2. Uncontrolled lethal arrhythmia despite K >4.5 mmol/l AND Mg >1.0 mmol/l AND Intubation and mechanical ventilation with deep sedation AND IV Loading of amiodarone AND IV xylocaine
- 3. Refractory cardiac arrest
Mandatory validation of rescue VA-ECMO by an independent adjudicator.
- Conditions
- Acute Myocardial Infarction, Cardiogenic Shock
- Being tested
- VA-ECMO
- Keywords
- cardiogenic shock, VA-ECMO, STEMI, NSTEMI, Intraortic balloon pump
- Medical subject headings
- Shock, Cardiogenic, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA-ECMODevice
- 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure at Day 30
Death in the ECMO group and death OR rescue ECMO in the control group
Measured: At day 30
Secondary outcomes (32)
Mortality at Day 30
All-cause mortality at day 30
Measured: At day 30
Major Adverse Cardiovascular Events
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.
Measured: At day 30
Stroke
Any new neurological symptoms in association with signs of ischemia or hemorrhage in a cranial CT or MRI
Measured: At day 30
Recurrent myocardial infarction
Recurrent myocardial infarction
Measured: At day 30
Need for repeat revascularization with PCI and/or CABG
Need for repeat revascularization (PCI and/or CABG)
Measured: At day 30
Need for renal replacement therapy
Need for renal replacement therapy
Measured: At day 30
Re-hospitalization for heart failure
re-hospitalization for heart failure
Measured: At day 30
Escalation to LVAD or total artificial heart
Escalation to permanent left ventricular assist device or total artificial heart
Measured: At day 30
Cardiac transplantation
Cardiac transplantation
Measured: At day 30
Major bleeding
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)
Measured: At day 30
Red blood cells transfused
Number of packed red blood cells transfused
Measured: At day 30
Serum lactate
Time to serum lactate normalization
Measured: At day 30
Number of days alive without organ failure at day 30
Number of days alive without organ failure(s) defined with the SOFA score, catecholamine support, mechanical ventilation and renal replacement therapy
Measured: At day 30
Durations of ICU stay and hospitalization
Durations of ICU stay and of hospitalization
Measured: At day 30
LV function
LV function assessed with Doppler echocardiography or magnetic resonance imaging
Measured: At day 30
NYHA/INTERMACS status
NYHA/INTERMACS status
Measured: At day 30
ECMO-related complications
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).
Measured: At day 30
Treatment failure 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.
Measured: At one year
Mortality at one year
All-cause mortality
Measured: At one year
Major Adverse Cardiovascular 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.
Measured: At one year
Stroke at one year
Stroke (any new neurological symptoms in association with signs of ischemia or hemorrhage in a cranial CT or MRI),
Measured: At one year
Recurrent myocardial infarction at one year
Recurrent myocardial infarction between randomization and one year
Measured: At one year
PCI and/or CABG at one year
Repeat revascularization (PCI and/or CABG) between randomization and one year
Measured: At one year
Renal replacement therapy at one year
Need for renal replacement therapy between randomization and one year
Measured: At one year
Re-hospitalization for heart failure
Re-hospitalization for heart failure between randomization and one year
Measured: At one year
LVAD at one year
Escalation to permanent left ventricular assist device (LVAD) or total artificial heart
Measured: At one year
Cardiac transplant at one year
Cardiac transplantation
Measured: At one year
Major bleeding 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)
Measured: At one year
NYHA/INTERMACS status at one year
NYHA/INTERMACS status
Measured: At one year
Returned to work at one year
Rate of patients who returned to work if previously active
Measured: At one year
LV ejection fraction at one year
Latest LV ejection fraction
Measured: At one year
Short Form 36 (SF-36) questionnaire at one year
Quality of life assessed using the Short Form 36 (SF-36) Health Survey questionnaire
Measured: At one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start14 Oct 2021
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain COMBES, MD, PhD, Principal investigator, Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184635
- Sponsor's protocol ID
- P140936
- Other IDs
- N°ID-RCB : 2019-A00275-52
- Acronym
- ANCHOR
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2019
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29083953Authors/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.
PubMed 25173339Thiele 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.
PubMed 30145971Overtchouk 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.
PubMed 29400656Muller 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.
PubMed 26825953
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)
- ClinicalTrials.gov ID
- NCT04184635
- Acronym / sponsor ID
- ANCHOR / P140936
- Conditions
- Acute Myocardial Infarction, Cardiogenic Shock
- Keywords
- cardiogenic shock, VA-ECMO, STEMI, NSTEMI, Intraortic balloon pump
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 14 Oct 2027 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Scientific background
- Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used more and more frequently in patients with acute myocardial infarction (AMI) and refractory cardiogenic shock despite the absence of high level scientific evidence to recommend the use of temporary circulatory support devices (TCS) in this setting.TCS support may also benefit to cardiogenic shock patients not initially refractory to conventional medical management since their mortality exceeds 40% and most of deaths are due to the development of refractory cardiogenic shock and multiple organ failure.
The ANCHOR trial is therefore designed to test the hypothesis that VA-ECMO support associated with IABP results in improved outcomes in comparison with optimal medical treatment alone in patients with AMI and cardiogenic shock. An ethical rescue option to VA-ECMO will however be provided to control patients with cardiogenic shock refractory to conventional medical treatment since recent data suggested survival up-to 50% with ECMO support in this setting.
Main objective - To determine if early VA-ECMO combined with IABP support and optimal medical treatment would improve the outcomes of patients with acute myocardial infarction complicated by cardiogenic shock as compared with optimal medical treatment alone.
Scope of the study
- Patients satisfying all of the Inclusion and Exclusion Criteria will be classified as 'Eligible'. Consent to research will be obtained from a close relative or surrogate for all eligible patients prior to randomization.
Should such a person be absent, eligible patients will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
Randomization will be possible in centers with robust experience in the management of AMI and cardiogenic shock but no on-site ECMO capability providing that an ECMO retrieval team from the nearest ECMO center can establish ECMO no later than 2 hours after randomization.
Before randomization, physicians at the non-ECMO center will check that the ECMO team is immediately available and that an ICU/CCU bed is available at the ECMO center. Thereafter, if the patient is randomized to the ECMO arm, the mobile ECMO retrieval team will travel to the center, initiate VA-ECMO and will rapidly transfer the patient on VA-ECMO to the ECMO center.
Description of experimental ECMO + IABP Arm
- Protocolized conventional management of cardiogenic shock
- VA-ECMO will be started as soon as possible
- For patients randomized at non-ECMO centers, a mobile ECMO team will initiate ECMO at the non-ECMO center and transport the patient to the ECMO center immediately
- IABP inserted in the contralateral femoral artery (unless technically not possible)
- ECMO management according to protocol
- ECMO weaning according to protocol
Description of conventional treatment Arm
- Protocolized conventional management of cardiogenic shock
- IABP not recommended. No other TCS device (e.g., ECMO, Impella, Thoratec PHP, TandemHeart) permitted
- Rescue VA-ECMO only if one of 1 or 2 or 3 applies:
- 1. Refractory cardiogenic shock defined as
- Cardiac index <1.2 l/min/m² or VTI <6 cm AND
- Assessment and correction of hypovolemia AND
- (dobutamine ≥15 microg/kg/min + norepinephrine ≥1.5 microg/kg/min) OR epinephrine ≥ 0.75 microg/kg/min
- Serum lactate >5 mmol/L or serum lactate increased >50% in the last 6 hours
- 2. Uncontrolled lethal arrhythmia despite K >4.5 mmol/l AND Mg >1.0 mmol/l AND Intubation and mechanical ventilation with deep sedation AND IV Loading of amiodarone AND IV xylocaine
- 3. Refractory cardiac arrest
Mandatory validation of rescue VA-ECMO by an independent adjudicator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicenter, prospective, randomized, comparative open trial will be conducted on two parallel groups of patients with AMI complicated by cardiogenic shock.
| Arm | Type | Receives |
|---|---|---|
| Experimental ECMO + IABP Arm | Experimental | Device: VA-ECMOVA-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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (16 listed)
- Age <18 years
- Pregnancy
- Onset of shock >24 Hours
- Shock of other cause (hypovolemic, anaphylactic or vagal shock)
- Shock due to massive pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Experimental ECMO + IABP Arm |
Primary outcome
Treatment failure at Day 30
Time frame: At day 30
Death in the ECMO group and death OR rescue ECMO in the control group
32 secondary outcomes
Mortality at Day 30
Time frame: At day 30
Major Adverse Cardiovascular Events
Time frame: At day 30
Stroke
Time frame: At day 30
Recurrent myocardial infarction
Time frame: At day 30
Need for repeat revascularization with PCI and/or CABG
Time frame: At day 30
Need for renal replacement therapy
Time frame: At day 30
Re-hospitalization for heart failure
Time frame: At day 30
Escalation to LVAD or total artificial heart
Time frame: At day 30
Cardiac transplantation
Time frame: At day 30
Major bleeding
Time frame: At day 30
Red blood cells transfused
Time frame: At day 30
Serum lactate
Time frame: At day 30
Number of days alive without organ failure at day 30
Time frame: At day 30
Durations of ICU stay and hospitalization
Time frame: At day 30
LV function
Time frame: At day 30
NYHA/INTERMACS status
Time frame: At day 30
ECMO-related complications
Time frame: At day 30
Treatment failure at one year
Time frame: At one year
Mortality at one year
Time frame: At one year
Major Adverse Cardiovascular at one year
Time frame: At one year
Stroke at one year
Time frame: At one year
Recurrent myocardial infarction at one year
Time frame: At one year
PCI and/or CABG at one year
Time frame: At one year
Renal replacement therapy at one year
Time frame: At one year
Re-hospitalization for heart failure
Time frame: At one year
LVAD at one year
Time frame: At one year
Cardiac transplant at one year
Time frame: At one year
Major bleeding at one year
Time frame: At one year
NYHA/INTERMACS status at one year
Time frame: At one year
Returned to work at one year
Time frame: At one year
LV ejection fraction at one year
Time frame: At one year
Short Form 36 (SF-36) questionnaire at one year
Time frame: At one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 29083953Thiele 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.
- Background: PubMed 25173339Authors/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.
- Background: PubMed 30145971Thiele 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.
- Background: PubMed 29400656Overtchouk 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.
- Background: PubMed 26825953Muller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alain COMBES, MD, PhD principal investigator
Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA-ECMO in people with Acute Myocardial Infarction and Cardiogenic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain COMBES, MD, PhD (01.42.16.38.16 ext. +33, alain.combes@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure at Day 30 (time frame: At day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04184635, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.