Caroline Hauw-Berlemont1, Lionel Lamhaut2, Jean-Luc Diehl3, Christophe Andreotti4, Olivier Varenne5, Pierre Leroux6, Jean-Baptiste Lascarrou7, Patrice Guerin8, Thomas Loeb9, Eric Roupie10, Cédric Daubin11, Farzin Beygui12, Aurélie Vilfaillot13, Sophie Glippa13, Juliette Djadi-Prat13, Gilles Chatellier13, Alain Cariou14, Christian Spaulding15. 1. Medical Intensive Care Unit, European Hospital Georges Pompidou, Assitance Publique-Hôpitaux de Paris, Paris Descartes University, Paris, France. 2. Paris Descartes University, Sorbonne Paris Cité-Medical School, Paris, France; Service d'Aide Médicale d'Urgence 75, Necker Hospital (APHP), Paris, France; INSERM U970 (team 4); Paris Cardiovascular Research Centre, Paris, France. 3. Medical Intensive Care Unit, European Hospital Georges Pompidou, Assitance Publique-Hôpitaux de Paris, Paris Descartes University, Paris, France; INSERM UMR-S1140, Paris University, Paris, France. 4. Service Mobile d'Urgence et de Réanimation - Emergency Department Cochin - Hôtel Dieu, Assistance Publique- Hôpitaux de Paris, Cochin Hospital, Paris, France. 5. Interventional Cardiology, Cardiology Department, Groupe Hospitalier Cochin-Saint Vincent de Paul-Hôtel Dieu, Cochin Hospital, Assistance Publique- Hôpitaux de Paris, Paris, France. 6. Service d'Aide Médicale d'Urgence (SAMU) 44, University Hospital of Nantes, Nantes, France. 7. Medical Intensive Care Unit, University Hospital of Nantes, Nantes, France. 8. Unité d'hémodynamique, L'institut du thorax. University Hospital of Nantes, Nantes, France. 9. Service d'Aide Médicale d'Urgence (SAMU) 92, Hôpitaux Universitaires Paris-Saclay, Site Raymond Poincaré, Garches, France. 10. Service d'Aide Médicale d'Urgence (SAMU) 14, University Hospital of Caen, Caen, France. 11. Medical Intensive Care Unit, University Hospital of Caen, Caen, France. 12. Cardiology Department, University Hospital of Caen, Caen, France. 13. INSERM CIC1418 and Département d'Informatique, Biostatistique et Santé publique, European Hospital Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France. 14. Medical Intensive Care Unit, Cochin Hospital, Assistance Publique- Hôpitaux de Paris, Centre - Université de Paris, Medical School, Paris, France. 15. Cardiology Department, European Hospital Georges Pompidou, Assistance Publique- Hôpitaux de Paris, Paris Descartes University, Sudden Cardiac Death Expert Center, INSERM U 971, Paris, France. Electronic address: christian.spaulding@egp.aphp.fr.
Abstract
BACKGROUND: In adults, the most common cause of out-of-hospital cardiac arrests (OHCA) is acute coronary artery occlusion. If an immediate coronary angiogram (CAG) is recommended for survivors presenting a ST segment elevation on the electrocardiogram (ECG) performed after resuscitation, there is still a debate regarding the best strategy in patients without ST segment elevation. HYPOTHESIS: Performing an immediate CAG after an OHCA without ST segment elevation on the post-resuscitation ECG and no obvious non-cardiac cause of arrest could lead to a better 180-day survival rate with no or minimal neurological sequel as compared with a delayed CAG performed 48 to 96 hours after the arrest. DESIGN: The EMERGE trial is a prospective national, randomized, open and parallel group trial, in which 970 survivors of OHCA will be randomized (1:1) to either immediate (as soon as possible after return of spontaneous circulation) or delayed (48 to 96 h) CAG. Participants will be OHCA patients with no ST segment elevation on the post resuscitation ECG and no obvious non-cardiac cause of arrest. The primary endpoint of the study is the 180-day survival rate with no or minimal neurological sequel corresponding to Cerebral Performance Category (CPC) 1 or 2. The secondary endpoints are: occurrence of shock during the first 48 hours, ventricular tachycardia and/or fibrillation during the first 48 hours, change in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram, neurological status evaluated by the CPC score at intensive care unit (ICU) discharge and day 90 neurological status assessed by the Glasgow Outcome Scale Extended score (GOSE) at 90 and 180 days, overall survival rate, and hospital length of stay. SUMMARY: The EMERGE trial is a prospective, multicenter, randomized, controlled trial that will assess the 180-day survival rate with no or minimal neurologic sequel in patients resuscitated from an OHCA without ST segment elevation and who will be managed with either immediate or delayed CAG.
RCT Entities:
BACKGROUND: In adults, the most common cause of out-of-hospital cardiac arrests (OHCA) is acute coronary artery occlusion. If an immediate coronary angiogram (CAG) is recommended for survivors presenting a ST segment elevation on the electrocardiogram (ECG) performed after resuscitation, there is still a debate regarding the best strategy in patients without ST segment elevation. HYPOTHESIS: Performing an immediate CAG after an OHCA without ST segment elevation on the post-resuscitation ECG and no obvious non-cardiac cause of arrest could lead to a better 180-day survival rate with no or minimal neurological sequel as compared with a delayed CAG performed 48 to 96 hours after the arrest. DESIGN: The EMERGE trial is a prospective national, randomized, open and parallel group trial, in which 970 survivors of OHCA will be randomized (1:1) to either immediate (as soon as possible after return of spontaneous circulation) or delayed (48 to 96 h) CAG. Participants will be OHCA patients with no ST segment elevation on the post resuscitation ECG and no obvious non-cardiac cause of arrest. The primary endpoint of the study is the 180-day survival rate with no or minimal neurological sequel corresponding to Cerebral Performance Category (CPC) 1 or 2. The secondary endpoints are: occurrence of shock during the first 48 hours, ventricular tachycardia and/or fibrillation during the first 48 hours, change in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram, neurological status evaluated by the CPC score at intensive care unit (ICU) discharge and day 90 neurological status assessed by the Glasgow Outcome Scale Extended score (GOSE) at 90 and 180 days, overall survival rate, and hospital length of stay. SUMMARY: The EMERGE trial is a prospective, multicenter, randomized, controlled trial that will assess the 180-day survival rate with no or minimal neurologic sequel in patients resuscitated from an OHCA without ST segment elevation and who will be managed with either immediate or delayed CAG.