European Georges Pompidou Hospital
Paris, 75015, France
NCT Number: NCT02876458
Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The most common cause of SCD is acute coronary artery occlusion. Several registry based studies suggest that coronary angiography (CA) performed at admission followed if necessary by coronary angioplasty improves in-hospital and long term survival. Recent guidelines recommend performing an immediate CA in all survivors of SCD with no obvious non cardiac cause of arrest. However there is a lack of randomized data on this topic.
Several retrospective studies have shown that if the post-resuscitation electrocardiogram (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion during the CA is high (70-80%). In contrast, if no ST segment elevation is present the probability is low (15-20%).
Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA. It may increase the delay of performing other therapeutic modalities such as CT brain or thorax scan to determine the cause of SCD. Performing the CA 48 to 96 hours after admission would facilitate the management of these difficult patients. However if the cause of the arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of post-arrest shock and the mortality may increase. Therefore a randomized study comparing immediate versus delayed (between 48 to 96 hours) CA in survivors of SCD with no obvious non-cardiac cause of arrest is warranted.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75015, France
The design consists in a multicenter national randomized open parallel group trial.
All eligible patients with SCD will be included and randomized by the Emergency Medical Service (EMS) to one of the 2 following arms: immediate CA vs delayed CA. Patients randomized in the immediate CA group will be admitted directly to the catheterization laboratory. Patients randomized in the delayed CA will be admitted to the intensive care unit and a CA will be planned 48 to 96 hours after admission. Investigators can perform the CA in the delayed group < 48 hours if the following events appear:
Echocardiography and assessment of neurological status are done at discharge form the Intensive Care Unit, at hospital discharge and during the follow-up visits (90 and 180 days).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An immediate coronary angiogram will be performed
A delayed coronary angiogram (between 48 to 96 hours) will be performed
Time frame: 180 days
Survival rate with no or minimal neurological sequel (CPC (cerebral performance category) 1 or 2) at 6 months after inclusion
Time frame: 48 hours
The rate of shock during the first 48 hours between immediate and delayed CA
Time frame: 48 hours
The rate of VT/VF during the first 48 hours between immediate and delayed CA
Time frame: 180 days
Changes in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram between immediate and delayed CA
Time frame: 180 days
The rate of neurological sequel assessed by the CPC score between immediate and delayed CA
Time frame: 180 days
The rate of neurological sequel assessed by the GOSE between immediate and delayed CA
Time frame: 180 days
The overall survival rate between immediate and delayed CA
Time frame: 180 days
The length of hospital stay between immediate and delayed CA
Assistance Publique - Hôpitaux de Paris
Other
EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest
Acronym: EMERGE
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.
Published trials that share one or more normalized conditions with this study.
NCT03835403
Cardiovascular Diseases, Heart Arrest
Copenhagen, Ballerup, Denmark
View Trial DetailsNCT02309151
Cardiovascular Diseases, Heart Arrest
Aalborg, Denmark
View Trial DetailsNCT04237727
Cardiovascular Diseases, Heart Arrest
Amersfoort, Utrecht, Netherlands
View Trial DetailsNCT05062785
Cardiovascular Diseases, Healthy
Ann Arbor, Michigan, United States
View Trial Details