Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardio… (NCT06046339) | Clinical Trial Compass
CompletedNot Applicable
Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardiopulmonary Resuscitation
France116 participantsStarted 2024-04-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantitative Assessment of Left Ventricular Ejection Fraction Using Ultrasound Values, 28 Days After Cardiac Arrest