Cardiogenic ShockELLIPSE1NCT06645990
Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump
An observational study of Cardiogenic Shock, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Over the past decade, VA-ECMO has become the main mechanical support for cardiogenic shock (CS) unresponsive to medical therapy. However, recent studies failed to show any significant survival benefit at 30 days compared to medical treatment for myocardial infarction-related CS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Impella and IABP
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2010to 30 Jan 2025
- Phase
- Observational
- 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
Study population: All Adult patients (more than or =18 years) admitted for Cardiogenic Shock supported by ECMO+ IABP or ECMELLA between January 1, 2010, and December 31, 2023
Who may be able to join
- Adult patients (more than or =18 years) admitted for cardiogenic shock supported by ECMO+ IABP or ECMELLA between January 1, 2010, and December 31, 2023
Who cannot join
- Ongoing extra-corporeal CardioPulmonary Resuscitation (eCPR) at time of ECMO implantation
- Cardiogenic shock with previous prolonged continuous cardiopulmonary resuscitation (CPR) more than 30 minutes
- Acute irreversible neurological injury
- Previous known severe chronic cardiomyopathy (LVEF less than 25%) or awaiting heart transplantation or LVAD implantation
- Contraindication to the implantation of an Impella or IABP
- Mechanical complications of myocardial infarction
Show all 9Show fewer
- Moribund patient (SAPS more than 90)
- Previous known severe chronic renal or hepatic failure
- Age less than18 years
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
CHU Arnaud de Villeneuve
Montpellier, 34295
About this study
Official title: Early Left Ventricular unLoading by Impella (ECMELLA) or Intra-aortic Balloon Pump for Cardiogenic Shock in Patients on VA-ECMO
Over the past decade, VA-ECMO has become the main mechanical support for cardiogenic shock (CS) unresponsive to medical therapy. However, recent studies failed to show any significant survival benefit at 30 days compared to medical treatment for myocardial infarction-related CS. This could be due to the complications of VA-ECMO, such as LV overload and increased LV distension, which can hinder heart recovery.
To address this, early LV unloading using devices like IABP or Impella (ECMELLA) may help by reducing LV wall stress and oxygen consumption. However, these techniques carry risks, and their benefit is still unclear. A randomized trial is needed to compare these approaches, but observational studies are also contributing to understanding the best strategies
Read the detailed description
Over the last decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has become the mechanical circulatory support of choice for cardiogenic shock (CS) refractory to medical treatment. VA-ECMO allows to supplement cardiac function until myocardium recovers, or in bridge to long-term left ventricular assist device (LVAD) or to heart transplant. However, recent randomized controlled trials (RCT) and meta-analysis have failed to demonstrate any benefit of VA-ECMO in terms of 30-day survival compared with optimal medical treatment in CS related to myocardial infarction.
Reasons for these disappointing results are multifactorial. The associated risk of temporary mechanical circulatory support (t-MCS)-related complications might counterbalance any hemodynamic benefit. In addition to hemorrhagic and ischemic complications, the significant myocardial impact due to VA-ECMO drawbacks should not be overlooked. Indeed, while VA-ECMO restores systemic perfusion, it can also lead to an increase in left ventricle (LV) loading conditions. Although LV distension is not consistently observed, recent publications strongly suggest that the origin of LV overload seems to be multifactorial and contributes partially to cardiac remodeling through the modulation of cardioprotective cellular pathways, resulting in reduced cardiomyocyte apoptosis. Furthermore, peripheral VA-ECMO affects myocardial contractility and increases myocardial work (potential energy, stroke work, and pressure-volume area), particularly at native low blood flow.
Thus, cardiac recovery may be compromised and weaning from VA-ECMO delayed. This vicious cycle affects the patients overall prognosis, as delayed and possibly failure of VA-ECMO weaning and may convert the initial medical strategy of recovery towards heart transplantation or LVAD. To optimize the chance of VA-ECMO weaning, early LV unloading may be a good therapeutic option. It aims at increasing coronary flow directly and, indirectly, by improving sub-endocardial myocardial perfusion through decreasing LV wall stress and myocardial oxygen consumption. Currently, 2 techniques are mainly used, the intra-aortic balloon pump (IABP) and the microaxial flow pump as Impella device familly (ECMELLA). These invasive techniques carry risks of bleeding and thromboembolic complications, and the benefit/risk ratio of their use for myocardial recovery is not clearly established.
A few retrospective studies suggest that early left ventricular unloading during VA-ECMO could improve prognosis. In the absence of RCT, the choice of the technique (Impella or IABP) is mainly driven by center practice. A multicenter randomized clinical trial would be the best choice to address this question. However, due to the acute poor prognosis of these patients (50% of early deaths), reliable preliminary data about the expected effect size are necessary to design the most efficient clinical trial. Recent epidemiologic developments of observational studies, the emulated trials, allow a better control of immortal time bias and indication bias.
This innovative multicenter study will compare the effectiveness and safety of LV unloading by Impella (ECMELLA) versus IABP in terms of survival with myocardial recovery in patients with refractory CS
- Conditions
- Cardiogenic Shock
- Being tested
- Impella, IABP
- Keywords
- ECMO, ECLS, Impella, IABP, pVAD, mortality
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImpellaDevice
LV unloading with Impella (ECMELLA) before or within 24 h of ECMO initiation
IABPDevice
LV unloading with IABP before or within 24 h of ECMO initiation
| Study group | Role | What they receive |
|---|---|---|
| ECMELLA group | VA-ECMO + Impella implemented before or within 24 h of ECMO initiation Receives: Device: Impella | |
| ECMO+IABP group | VA-ECMO + IABP implemented before or within 24h of ECMO initiation Receives: Device: IABP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial recovery
Hospital Survival without chronic mechanical circulatory support (LVAD) and heart transplantation.
Measured: from start of hospitalization until hospital discharge assessed up to 3 month
Secondary outcomes (6)
Early mortality
In-hospital all-cause mortality
Measured: from start of hospitalization until hospital discharge assessed up to 3 month
Adverse events related to LV unloading technics
Arterial thromboembolic events; Hemorrhagic events (RBC transfusion); Hemolysis; Bacteremia; Infection of the device insertion site or the device itself
Measured: from start of hospitalization until hospital discharge assessed up to 3 month
Duration of mechanical ventilation
Total duration of invasive mechanical ventilation
Measured: from start of hospitalization until hospital discharge assessed up to 3 month
Duration of temporary MCS support
Total duration of t-MCS
Measured: from start of hospitalization until hospital discharge assessed up to 3 month
Lengh of stay
Total and in intensive care unit lenght of stay
Measured: from start of hospitalization until hospital discharge assessed up to 3 month
Cardiac long-term project
Rate and % of patients with myocardial recovery, ventricular assist device or/and heart transplantation
Measured: from start of hospitalization until hospital discharge assessed up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Jan 2010
- Primary completion1 Jan 2023
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore UGHETTO, MD, Principal investigator, Montpellier University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645990
- Sponsor's protocol ID
- 2024-06-079
- Acronym
- ELLIPSE1
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
PubMed 35083827Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.
PubMed 21900289Hernan MA, Sauer BC, Hernandez-Diaz S, Platt R, Shrier I. Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses. J Clin Epidemiol. 2016 Nov;79:70-75. doi: 10.1016/j.jclinepi.2016.04.014. Epub 2016 May 27.
PubMed 27237061Hernan MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016 Apr 15;183(8):758-64. doi: 10.1093/aje/kwv254. Epub 2016 Mar 18.
PubMed 26994063Ezad SM, Ryan M, Donker DW, Pappalardo F, Barrett N, Camporota L, Price S, Kapur NK, Perera D. Unloading the Left Ventricle in Venoarterial ECMO: In Whom, When, and How? Circulation. 2023 Apr 18;147(16):1237-1250. doi: 10.1161/CIRCULATIONAHA.122.062371. Epub 2023 Apr 17.
PubMed 37068133Bernhardt AM, Copeland H, Deswal A, Gluck J, Givertz MM; Chairs:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:; Chair:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Heart Lung Transplant. 2023 Apr;42(4):e1-e64. doi: 10.1016/j.healun.2022.10.028. Epub 2023 Feb 6. No abstract available.
PubMed 36805198Ostadal P, Rokyta R, Karasek J, Kruger A, Vondrakova D, Janotka M, Naar J, Smalcova J, Hubatova M, Hromadka M, Volovar S, Seyfrydova M, Jarkovsky J, Svoboda M, Linhart A, Belohlavek J; ECMO-CS Investigators. Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. Circulation. 2023 Feb 7;147(6):454-464. doi: 10.1161/CIRCULATIONAHA.122.062949. Epub 2022 Nov 6.
PubMed 36335478Banning AS, Sabate M, Orban M, Gracey J, Lopez-Sobrino T, Massberg S, Kastrati A, Bogaerts K, Adriaenssens T, Berry C, Erglis A, Haine S, Myrmel T, Patel S, Buera I, Sionis A, Vilalta V, Yusuff H, Vrints C, Adlam D, Flather M, Gershlick AH. Venoarterial extracorporeal membrane oxygenation or standard care in patients with cardiogenic shock complicating acute myocardial infarction: the multicentre, randomised EURO SHOCK trial. EuroIntervention. 2023 Aug 21;19(6):482-492. doi: 10.4244/EIJ-D-23-00204.
PubMed 37334659Thiele H, Zeymer U, Akin I, Behnes M, Rassaf T, Mahabadi AA, Lehmann R, Eitel I, Graf T, Seidler T, Schuster A, Skurk C, Duerschmied D, Clemmensen P, Hennersdorf M, Fichtlscherer S, Voigt I, Seyfarth M, John S, Ewen S, Linke A, Tigges E, Nordbeck P, Bruch L, Jung C, Franz J, Lauten P, Goslar T, Feistritzer HJ, Poss J, Kirchhof E, Ouarrak T, Schneider S, Desch S, Freund A; ECLS-SHOCK Investigators. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock. N Engl J Med. 2023 Oct 5;389(14):1286-1297. doi: 10.1056/NEJMoa2307227. Epub 2023 Aug 26.
PubMed 37634145Schmidt M, Burrell A, Roberts L, Bailey M, Sheldrake J, Rycus PT, Hodgson C, Scheinkestel C, Cooper DJ, Thiagarajan RR, Brodie D, Pellegrino V, Pilcher D. Predicting survival after ECMO for refractory cardiogenic shock: the survival after veno-arterial-ECMO (SAVE)-score. Eur Heart J. 2015 Sep 1;36(33):2246-56. doi: 10.1093/eurheartj/ehv194. Epub 2015 Jun 1.
PubMed 26033984Muller 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 26825953Dickerman BA, Garcia-Albeniz X, Logan RW, Denaxas S, Hernan MA. Avoidable flaws in observational analyses: an application to statins and cancer. Nat Med. 2019 Oct;25(10):1601-1606. doi: 10.1038/s41591-019-0597-x. Epub 2019 Oct 7.
PubMed 31591592Meuwese CL, Koudstaal S, Braithwaite S, Hermens JAJ, Donker DW. Left Ventricular Unloading During Extracorporeal Membrane Oxygenation: Insights From Meta-Analyzed Observational Data Corrected for Confounders. J Am Coll Cardiol. 2019 Jun 18;73(23):3034-3035. doi: 10.1016/j.jacc.2019.03.505. No abstract available.
PubMed 31196464Beurton A, Michot M, Herion FX, Rienzo M, Oddos C, Couffinhal T, Imbault J, Ouattara A. Systemic Hemodynamics, Cardiac Mechanics, and Signaling Pathways Induced by Extracorporeal Membrane Oxygenation in a Cardiogenic Shock Model. ASAIO J. 2024 Mar 1;70(3):177-184. doi: 10.1097/MAT.0000000000002139. Epub 2024 Jan 23.
PubMed 38261663Ughetto A, Eliet J, Nagot N, David H, Bazalgette F, Marin G, Kollen S, Mourad M, Zeroual N, Muller L, Gaudard P, Colson P. Early temporary mechanical circulatory support for cardiogenic shock: Real-life data from a regional cardiac assistance network. J Heart Lung Transplant. 2024 Jun;43(6):911-919. doi: 10.1016/j.healun.2024.02.009. Epub 2024 Feb 15.
PubMed 38367739
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Left Ventricular unLoading by Impella (ECMELLA) or Intra-aortic Balloon Pump for Cardiogenic Shock in Patients on VA-ECMO
- ClinicalTrials.gov ID
- NCT06645990
- Acronym / sponsor ID
- ELLIPSE1 / 2024-06-079
- Conditions
- Cardiogenic Shock
- Keywords
- ECMO, ECLS, Impella, IABP, pVAD, mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 17 Oct 2024 (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.
Over the past decade, VA-ECMO has become the main mechanical support for cardiogenic shock (CS) unresponsive to medical therapy. However, recent studies failed to show any significant survival benefit at 30 days compared to medical treatment for myocardial infarction-related CS. This could be due to the complications of VA-ECMO, such as LV overload and increased LV distension, which can hinder heart recovery.
To address this, early LV unloading using devices like IABP or Impella (ECMELLA) may help by reducing LV wall stress and oxygen consumption. However, these techniques carry risks, and their benefit is still unclear. A randomized trial is needed to compare these approaches, but observational studies are also contributing to understanding the best strategies
Detailed description
Over the last decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has become the mechanical circulatory support of choice for cardiogenic shock (CS) refractory to medical treatment. VA-ECMO allows to supplement cardiac function until myocardium recovers, or in bridge to long-term left ventricular assist device (LVAD) or to heart transplant. However, recent randomized controlled trials (RCT) and meta-analysis have failed to demonstrate any benefit of VA-ECMO in terms of 30-day survival compared with optimal medical treatment in CS related to myocardial infarction.
Reasons for these disappointing results are multifactorial. The associated risk of temporary mechanical circulatory support (t-MCS)-related complications might counterbalance any hemodynamic benefit. In addition to hemorrhagic and ischemic complications, the significant myocardial impact due to VA-ECMO drawbacks should not be overlooked. Indeed, while VA-ECMO restores systemic perfusion, it can also lead to an increase in left ventricle (LV) loading conditions. Although LV distension is not consistently observed, recent publications strongly suggest that the origin of LV overload seems to be multifactorial and contributes partially to cardiac remodeling through the modulation of cardioprotective cellular pathways, resulting in reduced cardiomyocyte apoptosis. Furthermore, peripheral VA-ECMO affects myocardial contractility and increases myocardial work (potential energy, stroke work, and pressure-volume area), particularly at native low blood flow.
Thus, cardiac recovery may be compromised and weaning from VA-ECMO delayed. This vicious cycle affects the patients overall prognosis, as delayed and possibly failure of VA-ECMO weaning and may convert the initial medical strategy of recovery towards heart transplantation or LVAD. To optimize the chance of VA-ECMO weaning, early LV unloading may be a good therapeutic option. It aims at increasing coronary flow directly and, indirectly, by improving sub-endocardial myocardial perfusion through decreasing LV wall stress and myocardial oxygen consumption. Currently, 2 techniques are mainly used, the intra-aortic balloon pump (IABP) and the microaxial flow pump as Impella device familly (ECMELLA). These invasive techniques carry risks of bleeding and thromboembolic complications, and the benefit/risk ratio of their use for myocardial recovery is not clearly established.
A few retrospective studies suggest that early left ventricular unloading during VA-ECMO could improve prognosis. In the absence of RCT, the choice of the technique (Impella or IABP) is mainly driven by center practice. A multicenter randomized clinical trial would be the best choice to address this question. However, due to the acute poor prognosis of these patients (50% of early deaths), reliable preliminary data about the expected effect size are necessary to design the most efficient clinical trial. Recent epidemiologic developments of observational studies, the emulated trials, allow a better control of immortal time bias and indication bias.
This innovative multicenter study will compare the effectiveness and safety of LV unloading by Impella (ECMELLA) versus IABP in terms of survival with myocardial recovery in patients with refractory CS
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMELLA group | – | Device: ImpellaVA-ECMO + Impella implemented before or within 24 h of ECMO initiation |
| ECMO+IABP group | – | Device: IABPVA-ECMO + IABP implemented before or within 24h of ECMO initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Adult patients (more than or =18 years) admitted for Cardiogenic Shock supported by ECMO+ IABP or ECMELLA between January 1, 2010, and December 31, 2023
Key inclusion criteria (1 listed)
- Adult patients (more than or =18 years) admitted for cardiogenic shock supported by ECMO+ IABP or ECMELLA between January 1, 2010, and December 31, 2023
Key exclusion criteria (9 listed)
- Ongoing extra-corporeal CardioPulmonary Resuscitation (eCPR) at time of ECMO implantation
- Cardiogenic shock with previous prolonged continuous cardiopulmonary resuscitation (CPR) more than 30 minutes
- Acute irreversible neurological injury
- Previous known severe chronic cardiomyopathy (LVEF less than 25%) or awaiting heart transplantation or LVAD implantation
- Contraindication to the implantation of an Impella or IABP
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 |
|---|---|---|
| ImpellaLV unloading with Impella (ECMELLA) before or within 24 h of ECMO initiation | Device | ECMELLA group |
| IABPLV unloading with IABP before or within 24 h of ECMO initiation | Device | ECMO+IABP group |
Primary outcome
Myocardial recovery
Time frame: from start of hospitalization until hospital discharge assessed up to 3 month
Hospital Survival without chronic mechanical circulatory support (LVAD) and heart transplantation.
6 secondary outcomes
Early mortality
Time frame: from start of hospitalization until hospital discharge assessed up to 3 month
Adverse events related to LV unloading technics
Time frame: from start of hospitalization until hospital discharge assessed up to 3 month
Duration of mechanical ventilation
Time frame: from start of hospitalization until hospital discharge assessed up to 3 month
Duration of temporary MCS support
Time frame: from start of hospitalization until hospital discharge assessed up to 3 month
Lengh of stay
Time frame: from start of hospitalization until hospital discharge assessed up to 3 month
Cardiac long-term project
Time frame: from start of hospitalization until hospital discharge assessed up to 3 month
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 17 Oct 2024.
- Background: PubMed 35083827Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
- Background: PubMed 21900289Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.
- Background: PubMed 27237061Hernan MA, Sauer BC, Hernandez-Diaz S, Platt R, Shrier I. Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses. J Clin Epidemiol. 2016 Nov;79:70-75. doi: 10.1016/j.jclinepi.2016.04.014. Epub 2016 May 27.
- Background: PubMed 26994063Hernan MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016 Apr 15;183(8):758-64. doi: 10.1093/aje/kwv254. Epub 2016 Mar 18.
- Background: PubMed 37068133Ezad SM, Ryan M, Donker DW, Pappalardo F, Barrett N, Camporota L, Price S, Kapur NK, Perera D. Unloading the Left Ventricle in Venoarterial ECMO: In Whom, When, and How? Circulation. 2023 Apr 18;147(16):1237-1250. doi: 10.1161/CIRCULATIONAHA.122.062371. Epub 2023 Apr 17.
- Background: PubMed 36805198Bernhardt AM, Copeland H, Deswal A, Gluck J, Givertz MM; Chairs:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:; Chair:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Heart Lung Transplant. 2023 Apr;42(4):e1-e64. doi: 10.1016/j.healun.2022.10.028. Epub 2023 Feb 6. No abstract available.
- Results publication: PubMed 36335478Ostadal P, Rokyta R, Karasek J, Kruger A, Vondrakova D, Janotka M, Naar J, Smalcova J, Hubatova M, Hromadka M, Volovar S, Seyfrydova M, Jarkovsky J, Svoboda M, Linhart A, Belohlavek J; ECMO-CS Investigators. Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. Circulation. 2023 Feb 7;147(6):454-464. doi: 10.1161/CIRCULATIONAHA.122.062949. Epub 2022 Nov 6.
- Results publication: PubMed 37334659Banning AS, Sabate M, Orban M, Gracey J, Lopez-Sobrino T, Massberg S, Kastrati A, Bogaerts K, Adriaenssens T, Berry C, Erglis A, Haine S, Myrmel T, Patel S, Buera I, Sionis A, Vilalta V, Yusuff H, Vrints C, Adlam D, Flather M, Gershlick AH. Venoarterial extracorporeal membrane oxygenation or standard care in patients with cardiogenic shock complicating acute myocardial infarction: the multicentre, randomised EURO SHOCK trial. EuroIntervention. 2023 Aug 21;19(6):482-492. doi: 10.4244/EIJ-D-23-00204.
- Results publication: PubMed 37634145Thiele H, Zeymer U, Akin I, Behnes M, Rassaf T, Mahabadi AA, Lehmann R, Eitel I, Graf T, Seidler T, Schuster A, Skurk C, Duerschmied D, Clemmensen P, Hennersdorf M, Fichtlscherer S, Voigt I, Seyfarth M, John S, Ewen S, Linke A, Tigges E, Nordbeck P, Bruch L, Jung C, Franz J, Lauten P, Goslar T, Feistritzer HJ, Poss J, Kirchhof E, Ouarrak T, Schneider S, Desch S, Freund A; ECLS-SHOCK Investigators. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock. N Engl J Med. 2023 Oct 5;389(14):1286-1297. doi: 10.1056/NEJMoa2307227. Epub 2023 Aug 26.
- Results publication: PubMed 26033984Schmidt M, Burrell A, Roberts L, Bailey M, Sheldrake J, Rycus PT, Hodgson C, Scheinkestel C, Cooper DJ, Thiagarajan RR, Brodie D, Pellegrino V, Pilcher D. Predicting survival after ECMO for refractory cardiogenic shock: the survival after veno-arterial-ECMO (SAVE)-score. Eur Heart J. 2015 Sep 1;36(33):2246-56. doi: 10.1093/eurheartj/ehv194. Epub 2015 Jun 1.
- Results publication: 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.
- Results publication: PubMed 31591592Dickerman BA, Garcia-Albeniz X, Logan RW, Denaxas S, Hernan MA. Avoidable flaws in observational analyses: an application to statins and cancer. Nat Med. 2019 Oct;25(10):1601-1606. doi: 10.1038/s41591-019-0597-x. Epub 2019 Oct 7.
- Individual participant dataSharing planned: Undecided
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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.
Aurore UGHETTO, MD principal investigator
Montpellier University Hospital, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by University Hospital, Montpellier 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 1 inclusion and 9 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 17 Oct 2024. 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 Aurore UGHETTO, MD (0033622054893, a-ughetto@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial recovery (time frame: from start of hospitalization until hospital discharge assessed up to 3 month). 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 NCT06645990, which also lists 15 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 17 Oct 2024.