Out-of-Hospital Cardiac ArrestEMERGENCT02876458
EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest
A study testing Immediate coronary angiogram and Delayed coronary angiogram in people with Out-of-Hospital Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- Immediate coronary angiogram and Delayed coronary angiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 23 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-of-hospital SCD with return of spontaneous circulation
- Age ≥ 18 years of age
- No obvious non-cardiac cause of arrest
- Admitted to a center with an intensive care unit and a 24 hours a day, 7 days a week interventional cardiology department
- Affiliation to the French Social Security Health Care plan
Who cannot join
- Age < 18 years of age
- In-hospital SCD
- No return of spontaneous circulation
- Presence of ST segment elevation
- Suspected non-cardiac aetiology (trauma, respiratory, neurological, etc.)
- Presence of co-morbidities with life expectancy of less than a year
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- Pregnancy
- Adults subject to a legal protection measure (guardianship or tutelage measure)
- Participation in another interventional trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest
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.
Read the detailed description
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:
- ST segment elevation or new left bundle branch block on the ECG
- Shock unresponsive to inotropes
- "Electrical storm" (repeated Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF))
- Segmental hypokinesia or akinesia on an echocardiogram
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).
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- Immediate coronary angiogram, Delayed coronary angiogram
- Keywords
- Coronary angiogram, Survival rate, Neurological sequel
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate coronary angiogramOther
An immediate coronary angiogram will be performed
Delayed coronary angiogramOther
A delayed coronary angiogram (between 48 to 96 hours) will be performed
| Study group | Role | What they receive |
|---|---|---|
| Immediate coronary angiogram | Other | An immediate coronary angiogram will be performed Receives: Other: Immediate coronary angiogram |
| Delayed coronary angiogram | Other | A delayed coronary angiogram (between 48 to 96 hours) will be performed Receives: Other: Delayed coronary angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 days
Secondary outcomes (7)
Shock
The rate of shock during the first 48 hours between immediate and delayed CA
Measured: 48 hours
Arrhythmia
The rate of VT/VF during the first 48 hours between immediate and delayed CA
Measured: 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
Measured: 180 days
CPC score
The rate of neurological sequel assessed by the CPC score between immediate and delayed CA
Measured: 180 days
Glasgow Outcome Scale Extended score (GOSE)
The rate of neurological sequel assessed by the GOSE between immediate and delayed CA
Measured: 180 days
Overall survival rate
The overall survival rate between immediate and delayed CA
Measured: 180 days
Hospital stay length
The length of hospital stay between immediate and delayed CA
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startJan 2017
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Christian Spaulding, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876458
- Sponsor's protocol ID
- P150914
- Other IDs
- 2016-A00413-48, PHRC-15-15-0570
- Acronym
- EMERGE
- Status last verified
- Oct 2021
- First submitted
- 31 Jul 2016
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35675081
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest
- ClinicalTrials.gov ID
- NCT02876458
- Acronym / sponsor ID
- EMERGE / P150914
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Coronary angiogram, Survival rate, Neurological sequel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2017 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- ST segment elevation or new left bundle branch block on the ECG
- Shock unresponsive to inotropes
- "Electrical storm" (repeated Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF))
- Segmental hypokinesia or akinesia on an echocardiogram
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate coronary angiogram | Other | Other: Immediate coronary angiogramAn immediate coronary angiogram will be performed |
| Delayed coronary angiogram | Other | Other: Delayed coronary angiogramA delayed coronary angiogram (between 48 to 96 hours) will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Out-of-hospital SCD with return of spontaneous circulation
- Age ≥ 18 years of age
- No obvious non-cardiac cause of arrest
- Admitted to a center with an intensive care unit and a 24 hours a day, 7 days a week interventional cardiology department
- Affiliation to the French Social Security Health Care plan
Key exclusion criteria (9 listed)
- Age < 18 years of age
- In-hospital SCD
- No return of spontaneous circulation
- Presence of ST segment elevation
- Suspected non-cardiac aetiology (trauma, respiratory, neurological, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate coronary angiogramAn immediate coronary angiogram will be performed | Other | Immediate coronary angiogram |
| Delayed coronary angiogramA delayed coronary angiogram (between 48 to 96 hours) will be performed | Other | Delayed coronary angiogram |
Primary outcome
Survival with no or minimal neurological sequel
Time frame: 180 days
Survival rate with no or minimal neurological sequel (CPC (cerebral performance category) 1 or 2) at 6 months after inclusion
7 secondary outcomes
Shock
Time frame: 48 hours
Arrhythmia
Time frame: 48 hours
The evolution of left ventricular ejection fraction evolution
Time frame: 180 days
CPC score
Time frame: 180 days
Glasgow Outcome Scale Extended score (GOSE)
Time frame: 180 days
Overall survival rate
Time frame: 180 days
Hospital stay length
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 35675081Hauw-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Spaulding, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate coronary angiogram and Delayed coronary angiogram in people with Out-of-Hospital Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival with no or minimal neurological sequel (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02876458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.