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Completed

NCT Number: NCT06046339

Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of data from the patient's medical file

Other

Collection of data from the patient's medical file.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: FEVGECMO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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