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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00413-48 | Other Identifier | ANSM | |
| PHRC-15-15-0570 | Other Grant/Funding Number | French Ministry of Health |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate coronary angiogram | Other | An immediate coronary angiogram will be performed |
|
| Delayed coronary angiogram | Other | A delayed coronary angiogram (between 48 to 96 hours) will be performed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate coronary angiogram | Other | An immediate coronary angiogram will be performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival with no or minimal neurological sequel | Survival rate with no or minimal neurological sequel (CPC (cerebral performance category) 1 or 2) at 6 months after inclusion | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Shock | The rate of shock during the first 48 hours between immediate and delayed CA | 48 hours |
| Arrhythmia | The rate of VT/VF during the first 48 hours between immediate and delayed CA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Spaulding, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Georges Pompidou Hospital | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35675081 | Derived | Hauw-Berlemont C, Lamhaut L, Diehl JL, Andreotti C, Varenne O, Leroux P, Lascarrou JB, Guerin P, Loeb T, Roupie E, Daubin C, Beygui F, Boissier F, Marjanovic N, Christiaens L, Vilfaillot A, Glippa S, Prat JD, Chatellier G, Cariou A, Spaulding C; EMERGE Investigators. Emergency vs Delayed Coronary Angiogram in Survivors of Out-of-Hospital Cardiac Arrest: Results of the Randomized, Multicentric EMERGE Trial. JAMA Cardiol. 2022 Jul 1;7(7):700-707. doi: 10.1001/jamacardio.2022.1416. |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Delayed coronary angiogram | Other | A delayed coronary angiogram (between 48 to 96 hours) will be performed |
|
| 48 hours |
| The evolution of left ventricular ejection fraction evolution | Changes in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram between immediate and delayed CA | 180 days |
| CPC score | The rate of neurological sequel assessed by the CPC score between immediate and delayed CA | 180 days |
| Glasgow Outcome Scale Extended score (GOSE) | The rate of neurological sequel assessed by the GOSE between immediate and delayed CA | 180 days |
| Overall survival rate | The overall survival rate between immediate and delayed CA | 180 days |
| Hospital stay length | The length of hospital stay between immediate and delayed CA | 180 days |