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

September 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker-Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized at Necker Hospital for an extra-hospital cardiac arrest between January 1, 2015 and October 31, 2019.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients hospitalized at Necker Hospital for an extra-hospital cardiac arrest between January 1, 2015 and October 31, 2019.
Other: Collection of data from the patient's medical file
Collection of data from the patient's medical file.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 28 days after cardiac arrest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Assessment of Left Ventricular Ejection Fraction Using Ultrasound Values, 90 Days After Cardiac Arrest
Time Frame: At 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
Survival
Time Frame: At 28 and at 90 days after cardiac arrest
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC Necker Cochin, France

Investigators

  • Principal Investigator: Jean-Herlé RAPHALEN, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

May 4, 2024

Study Completion (Actual)

May 4, 2024

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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