Out-of-Hospital Cardiac ArrestFEVGECMONCT06046339
Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardiopulmonary Resuscitation
An observational study of Out-of-Hospital Cardiac Arrest and Extracorporeal Cardiopulmonary Resuscitation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Extracorporeal Cardiopulmonary Resuscitation
- What is being tested?
- Collection of data from the patient's medical file
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2024to 4 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients hospitalized at Necker Hospital for an extra-hospital cardiac arrest between January 1, 2015 and October 31, 2019.
Who may be able to join
- Implementation of an extracorporeal membrane oxygenation (ECMO) following an acute coronary syndrome (ACS) defined for the purposes of the study by the existence of at least one of the following criteria: ST segment elevation or depression on the electrocardiogram associated with chest pain and elevated plasma troponin levels; a coronary angiography showing at least one significant coronary lesion and/or having required revascularization. Confirmation of an ischemic etiology by post-mortem examination. A coronary lesion is considered significant if it is described by the cardiologist as: acute and responsible for a reduction in the caliber of the artery strictly greater than 70% and less than 99% for a severe stenosis, and 100% for a complete stenosis.
- Patients hospitalized at Necker Hospital for pre-hospital cardiac arrest between January 1, 2015 and October 31, 2019.
- Sending to living patients of the study information note, a period of one month is given to the patients to oppose the use of their data for the study.
Who cannot join
- Extracorporeal membrane oxygenation implementation outside the context of refractory out-of-hospital cardiac arrest
- In-hospital cardiac arrests
- Obvious non-cardiological cause of cardiac arrest
- Cardiac arrests unrelated to acute coronary syndrome
- Cardiac arrests for which no etiology has been found
- Patients opposed to the use of their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Left Ventricular Ejection Fraction After Treatment of Out-of-hospital Cardiac Arrest by Extracorporeal Cardiopulmonary Resuscitation
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published.
After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population.
It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae.
Read the detailed description
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published.
After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population.
It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae.
The research focuses on the evolution of left ventricular function at 28 and 90 days after an out-of-hospital refractory cardiac arrest treated with ECPR as well as describing the survival rate at 28 and 90 days for these patients.
The expected results are to demonstrate that the left ventricular function, described through the left ventricular ejection fraction, is seriously affected in the population studied without signs of reversibility. These patients would therefore need close cardiological follow-up and to be integrated into a dedicated care pathway.
- Being tested
- Collection of data from the patient's medical file
- Keywords
- Out-of-Hospital Cardiac Arrest, Extracorporeal cardiopulmonary resuscitation, Left ventricular function, Left ventricular ejection fraction
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of data from the patient's medical fileOther
Collection of data from the patient's medical file.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients hospitalized at Necker Hospital for an extra-hospital cardiac arrest between January 1, 2015 and October 31, 2019. Receives: Other: Collection of data from the patient's medical file |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Assessment of Left Ventricular Ejection Fraction Using Ultrasound Values, 28 Days After Cardiac Arrest
Left ventricular ejection fraction value at 28 days after out-of-hospital cardiac arrest treated by extracorporeal cardiopulmonary resuscitation.
Measured: At 28 days after cardiac arrest
Secondary outcomes (2)
Quantitative Assessment of Left Ventricular Ejection Fraction Using Ultrasound Values, 90 Days After Cardiac Arrest
Left ventricular ejection fraction value at 90 days after out-of-hospital cardiac arrest treated by extracorporeal cardiopulmonary resuscitation.
Measured: At 90 days after cardiac arrest
Survival
Survival rate at 28 days and at 90 days after out-of-hospital cardiac arrest treated by extracorporeal cardiopulmonary resuscitation.
Measured: At 28 and at 90 days after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start24 Apr 2024
- Primary completion4 May 2024
- Study completion4 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Herlé RAPHALEN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046339
- Sponsor's protocol ID
- APHP230308
- Acronym
- FEVGECMO
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luc G, Baert V, Escutnaire J, Genin M, Vilhelm C, Di Pompeo C, Khoury CE, Segal N, Wiel E, Adnet F, Tazarourte K, Gueugniaud PY, Hubert H; On behalf GR-ReAC. Epidemiology of out-of-hospital cardiac arrest: A French national incidence and mid-term survival rate study. Anaesth Crit Care Pain Med. 2019 Apr;38(2):131-135. doi: 10.1016/j.accpm.2018.04.006. Epub 2018 Apr 21.
PubMed 29684654Registre électronique des arrêts cardiaques. Données du 1 er juillet 2011 au 31 mai 2021. Adresse : https://registreac.org/.
Soar J, Bottiger BW, Carli P, Couper K, Deakin CD, Djarv T, Lott C, Olasveengen T, Paal P, Pellis T, Perkins GD, Sandroni C, Nolan JP. European Resuscitation Council Guidelines 2021: Adult advanced life support. Resuscitation. 2021 Apr;161:115-151. doi: 10.1016/j.resuscitation.2021.02.010. Epub 2021 Mar 24.
PubMed 33773825Hutin A, Abu-Habsa M, Burns B, Bernard S, Bellezzo J, Shinar Z, Torres EC, Gueugniaud PY, Carli P, Lamhaut L. Early ECPR for out-of-hospital cardiac arrest: Best practice in 2018. Resuscitation. 2018 Sep;130:44-48. doi: 10.1016/j.resuscitation.2018.05.004. Epub 2018 May 5.
PubMed 29738799Gupta A, Gupta A, Saba S. Change in myocardial function after resuscitated sudden cardiac arrest and its impact on long-term mortality and defibrillator implantation. Indian Pacing Electrophysiol J. 2019 Jul-Aug;19(4):150-154. doi: 10.1016/j.ipej.2019.04.005. Epub 2019 Apr 22.
PubMed 31022454Khoury J, Soumagnac T, Vimpere D, El Morabity A, Hutin A, Raphalen JH, Lamhaut L. Long-term heart function in refractory out-of-hospital cardiac arrest treated with prehospital extracorporeal cardiopulmonary resuscitation. Resuscitation. 2025 Feb;207:110449. doi: 10.1016/j.resuscitation.2024.110449. Epub 2024 Nov 30.
PubMed 39622448
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Left Ventricular Ejection Fraction After Treatment of Out-of-hospital Cardiac Arrest by Extracorporeal Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT06046339
- Acronym / sponsor ID
- FEVGECMO / APHP230308
- Keywords
- Out-of-Hospital Cardiac Arrest, Extracorporeal cardiopulmonary resuscitation, Left ventricular function, Left ventricular ejection fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 4 May 2024 (actual)
- Study completion
- 4 May 2024 (actual)
- First posted
- 21 Sep 2023 (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.
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published.
After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population.
It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae.
Detailed description
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published.
After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population.
It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae.
The research focuses on the evolution of left ventricular function at 28 and 90 days after an out-of-hospital refractory cardiac arrest treated with ECPR as well as describing the survival rate at 28 and 90 days for these patients.
The expected results are to demonstrate that the left ventricular function, described through the left ventricular ejection fraction, is seriously affected in the population studied without signs of reversibility. These patients would therefore need close cardiological follow-up and to be integrated into a dedicated care pathway.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Collection of data from the patient's medical filePatients hospitalized at Necker Hospital for an extra-hospital cardiac arrest between January 1, 2015 and October 31, 2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized at Necker Hospital for an extra-hospital cardiac arrest between January 1, 2015 and October 31, 2019.
Key inclusion criteria (3 listed)
- Implementation of an extracorporeal membrane oxygenation (ECMO) following an acute coronary syndrome (ACS) defined for the purposes of the study by the existence of at least one of the following criteria: ST segment elevation or depression on the electrocardiogram associated with chest pain and elevated plasma troponin levels; a coronary angiography showing at least one significant coronary lesion and/or having required revascularization. Confirmation of an ischemic etiology by post-mortem examination. A coronary lesion is considered significant if it is described by the cardiologist as: acute and responsible for a reduction in the caliber of the artery strictly greater than 70% and less than 99% for a severe stenosis, and 100% for a complete stenosis.
- Patients hospitalized at Necker Hospital for pre-hospital cardiac arrest between January 1, 2015 and October 31, 2019.
- Sending to living patients of the study information note, a period of one month is given to the patients to oppose the use of their data for the study.
Key exclusion criteria (6 listed)
- Extracorporeal membrane oxygenation implementation outside the context of refractory out-of-hospital cardiac arrest
- In-hospital cardiac arrests
- Obvious non-cardiological cause of cardiac arrest
- Cardiac arrests unrelated to acute coronary syndrome
- Cardiac arrests for which no etiology has been found
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 |
|---|---|---|
| Collection of data from the patient's medical fileCollection of data from the patient's medical file. | Other | Patients |
Primary outcome
Quantitative Assessment of Left Ventricular Ejection Fraction Using Ultrasound Values, 28 Days After Cardiac Arrest
Time frame: At 28 days after cardiac arrest
Left ventricular ejection fraction value at 28 days after out-of-hospital cardiac arrest treated by extracorporeal cardiopulmonary resuscitation.
2 secondary outcomes
Quantitative Assessment of Left Ventricular Ejection Fraction Using Ultrasound Values, 90 Days After Cardiac Arrest
Time frame: At 90 days after cardiac arrest
Survival
Time frame: At 28 and at 90 days after cardiac arrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 29684654Luc G, Baert V, Escutnaire J, Genin M, Vilhelm C, Di Pompeo C, Khoury CE, Segal N, Wiel E, Adnet F, Tazarourte K, Gueugniaud PY, Hubert H; On behalf GR-ReAC. Epidemiology of out-of-hospital cardiac arrest: A French national incidence and mid-term survival rate study. Anaesth Crit Care Pain Med. 2019 Apr;38(2):131-135. doi: 10.1016/j.accpm.2018.04.006. Epub 2018 Apr 21.
- BackgroundRegistre électronique des arrêts cardiaques. Données du 1 er juillet 2011 au 31 mai 2021. Adresse : https://registreac.org/.
- Background: PubMed 33773825Soar J, Bottiger BW, Carli P, Couper K, Deakin CD, Djarv T, Lott C, Olasveengen T, Paal P, Pellis T, Perkins GD, Sandroni C, Nolan JP. European Resuscitation Council Guidelines 2021: Adult advanced life support. Resuscitation. 2021 Apr;161:115-151. doi: 10.1016/j.resuscitation.2021.02.010. Epub 2021 Mar 24.
- Background: PubMed 29738799Hutin A, Abu-Habsa M, Burns B, Bernard S, Bellezzo J, Shinar Z, Torres EC, Gueugniaud PY, Carli P, Lamhaut L. Early ECPR for out-of-hospital cardiac arrest: Best practice in 2018. Resuscitation. 2018 Sep;130:44-48. doi: 10.1016/j.resuscitation.2018.05.004. Epub 2018 May 5.
- Background: PubMed 31022454Gupta A, Gupta A, Saba S. Change in myocardial function after resuscitated sudden cardiac arrest and its impact on long-term mortality and defibrillator implantation. Indian Pacing Electrophysiol J. 2019 Jul-Aug;19(4):150-154. doi: 10.1016/j.ipej.2019.04.005. Epub 2019 Apr 22.
- Results publication: PubMed 39622448Khoury J, Soumagnac T, Vimpere D, El Morabity A, Hutin A, Raphalen JH, Lamhaut L. Long-term heart function in refractory out-of-hospital cardiac arrest treated with prehospital extracorporeal cardiopulmonary resuscitation. Resuscitation. 2025 Feb;207:110449. doi: 10.1016/j.resuscitation.2024.110449. Epub 2024 Nov 30.
- Individual participant dataSharing planned: No
Related trials for Out-of-Hospital Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
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. This study is not recruiting at the moment.
Jean-Herlé RAPHALEN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Out-of-Hospital Cardiac Arrest and Extracorporeal Cardiopulmonary Resuscitation, 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 12 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Assessment of Left Ventricular Ejection Fraction Using Ultrasound Values, 28 Days After Cardiac Arrest (time frame: At 28 days after cardiac arrest). 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 NCT06046339, which also lists 6 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 12 Sep 2025.