Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardiopulmonary Resuscitation

Out-of-Hospital Cardiac Arrest Clinical Trial

— FEVGECMO  

Official title:

Evolution of Left Ventricular Ejection Fraction After Treatment of Out-of-hospital Cardiac Arrest by Extracorporeal Cardiopulmonary Resuscitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06046339
• Other study ID #: APHP230308
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: January 2024

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean-Herlé RAPHALEN, MD
• Phone: 1 87 89 29 63
• Email: jena-herle.raphalen[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Extracorporeal Cardiopulmonary Resuscitation
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• Collection of data from the patient's medical file
Collection of data from the patient's medical file.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

Gupta 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. — View Citation

Hutin 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. — View Citation

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. — View Citation

Registre 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. Erratum In: Resuscitation. 2021 Oct;167:105-106. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 28 days after cardiac arrest
Secondary	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.	At 90 days after cardiac arrest
Secondary	Survival	Survival rate at 28 days and at 90 days after out-of-hospital cardiac arrest treated by extracorporeal cardiopulmonary resuscitation.	At 28 and at 90 days after cardiac arrest