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Prehospital Cardio-Respiratory ArrestsACENCT03494153

Early Echographic Asystole as a Predictive Factor of Absence of Spontaneous Circulatory Activity Recovery (SCAR) in Prehospital Cardio Respiratory Arrests (CRA)

An observational study of Prehospital Cardio-Respiratory Arrests and Spontaneous Circulatory Activity Recovery, run by Nantes University Hospital at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Assessment of prognostic performances of CCU in CRA Recovery (CRAR) has already been explored but 1) Only in intra-hospital medicine, 2) in very variable timings. ACE Research focuses on the extra-hospital window and predictive value of Early CCU (within 12 minutes of rescucitation initiation) with ambitious endpoints… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Non applicable - Non interventional study
How many people
346 participants
Where
7 sitesFrance
Study dates
23 Jan 2019to 23 Jan 2023
Phase
Observational
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
  • Adult, Older adult

Study population: All adult patients receiving resuscitation by the SMUR team in an CRA are eligible

Who may be able to join

  • Adult (>18yo) presenting extra-hospital CRA.

Who cannot join

  • Resuscitation refusal.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites
  • Chu Angers

    Angers, 49000

  • Chru Brest

    Brest, 29609

  • Ch Chateaubriant

    Châteaubriant, 44036

  • Chd Vendee

    La Roche-sur-Yon, 85000

  • Nantes University Hospital

    Nantes, 44093

  • CH Saint-Nazaire

    Saint-Nazaire, 44600

  • Chru Tours

    Tours, 37000

Other trials in France

About this study

Official title: Early Echographic Asystole as a Predictive Factor of Absence of Spontaneous Circulatory Activity Recovery (SCAR) in Prehospital Cardio Respiratory Arrests (CRA) - ACE Study

Assessment of prognostic performances of CCU in CRA Recovery (CRAR) has already been explored but 1) Only in intra-hospital medicine, 2) in very variable timings. ACE Research focuses on the extra-hospital window and predictive value of Early CCU (within 12 minutes of rescucitation initiation) with ambitious endpoints : curable etiologies identification, early anticipation of ECMO procedures, early anticipation of organ donation process, and evaluation of intrinsic contribution criterion to resuscitation interruption.

The primary objective of ACE study is to investigate the positive predictive value (PPV) of early ultrasound asystole on the absence of CRAR. The secondary objectives are multiple and innovative despite an observational design: impact on the morbi-mortality of the target population (frequency of curable etiologies, pre-therapeutic and therapeutic delays, morbidity...), delay of ECMO implementation of an ECMO (Extracorporeal Membrane Oxygenation), failure rate of organ donation due to overdelays, construction of a multifactorial score associated with CRAR.

Read the detailed description

Prehospital Cardio-Respiratory Arrests (CRA) represent a significant cause of mortality in France (between 30,000 and 50,000 cases per year) [1]. The prognosis is particularly pejorative, since only 5 to 6% of patients will leave the hospital alive with satisfying neurological condition [2,3]. Their management in France is part of a very singular Primary Care System, based on the medicalization of medical regulation (SAMU) and effectiveness (SMUR) and is based mainly on European recommendations (cardiac massage, ventilation and cardiac rhythm analysis) [4]). European 2015 recommendations advocate for the use of Cardiac Clinical Ultrasound (CCU) in Emergency Medicine, particularly to identify curable causes of CRA. Indeed, CCU is likely to reveal various curable etiologies as tamponade, massive pulmonary embolism, deep hypovolemia or suffocating pneumothorax[5]. Their identification allows the clinician to better adjust his therapeutic strategy and consequently improve patient prognosis.

But its predictive value on the absence of Spontaneous Circulatory Activity Recovery (SCAR) focus clinicians' interest due to its impact on extracorporeal circulation procedures, organ donation or resuscitation interruption guideline. Several studies support the predictive value associated with the absence of mechanical cardiac activity and resuscitation failure [5-10]. However, proof level remains very shaky and transposition to prehospital medicine is clearly impossible (delays, management and environment differ largely). As a corollary, the European Resuscitation Council (ERC) ruled in 2015 that the prognostic performances of ultrasound asystole had not been sufficiently finely measured to consider it as a rigorous criterion for resuscitation interruption, appealing for pivotal studies [4].

ACE French National Trial fits precisely into this bibliographic gap. Our objectives are multiple: assess prognostic value of Early CCU (ECCU; ie. <M12), alone or combined with other clinical parameters (composite prognostic tool combining myocardial and/or electrical activity, capnography, No/Low Flow duration, and clinical profile -sex, age-) on the absence of SCAR ; describe frequency and typology of curable etiologies in the context of CRA, and estimate the possible prognostic impact of early CCU on morbidity and mortality; finally, in case of validation of its prognostic performances, estimate theoretical time savings on ECMO (Extracorporeal Membrane Oxygenation) and organ donation processes.

Multicentric, based on rigorous methodology, high proof-level design and large sample (N=345), ACE wants to be resolutely pragmatic, by associating peripheric hospital and university hospital (Expertise), urban or rural environment (delays and intervention conditions), in order to answer definitely clinicians questioning of the emergency physicians. Continuing in the same vein, we aim a future validation study of a decision-making algorithm for pre-hospital management of CRAs to reduce morbidity and (Randomized Cluster Study in Stepped-Wedge integrating a medico-economic component).

Being tested
Non applicable - Non interventional study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non applicable - Non interventional studyOther

    Non interventional study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess prognostic value of early echographic (ECCU) asystole (i.e. within the first 12 minutes of resuscitation) on resuscitation failure (absence of CRAR).

    Patient in CRAR with extra-hospital care

    Measured: 1 month

Secondary outcomes (4)
  1. Assess prognostic value of an early echographic (ECCU) asystole (i.e. within the first 12 minutes of resuscitation) on morbi-mortality evaluated at 30 days

    Positive predictive value of ultrasound asystole within 12 minutes of the start of specialized CPR on the occurrence of death and/or sequelae at 30 days

    Measured: 1 month

  2. Measure variations of the prognostic performances of the extra-hospital ECCU according to their timing of realization, on the absence of CRAR

    Sensitive, specificity, negative predictive value, likelihood ratios of early ultrasound asystole to absence of CRAR

    Measured: 1 month

  3. Study the link between ultrasound diagnosis and electrocardiogram electrical plots.

    Recorded electrical activity patterns:

    Measured: 1 month

  4. Creation of a multifactorial composite prognostic score associated with the absence of CRAR

    composite score

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study start23 Jan 2019
  3. Primary completion23 Jan 2023
  4. Study completion23 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03494153
Sponsor's protocol ID
RC17_0464
Acronym
ACE
Status last verified
Apr 2023
First submitted
29 Mar 2018
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Javaudin F, Papin M, Le Bastard Q, Thibault M, Boishardy T, Brau F, Laribi S, Petrovic T, Peluchon T, Markarian T, Volteau C, Arnaudet I, Pes P, Le Conte P. Early point-of-care echocardiography as a predictive factor for absence of return of spontaneous circulatory in out-of-hospital cardiac arrests: A multicentre observational study. Resuscitation. 2024 Oct;203:110373. doi: 10.1016/j.resuscitation.2024.110373. Epub 2024 Aug 21.

    PubMed 39174002
  • Papin M, Markarian T, Le Bastard Q, Volteau C, Pes P, Le Conte P, Javaudin F. Inter-rater reliability of point-of-care ultrasound during out-of-hospital cardiac arrest: an ancillary analysis of the observational prospective ACE trial. Resusc Plus. 2025 Dec 13;27:101191. doi: 10.1016/j.resplu.2025.101191. eCollection 2026 Jan.

    PubMed 41583929
  • Javaudin F, Pes P, Montassier E, Legrand A, Ordureau A, Volteau C, Arnaudet I, Le Conte P. Early point-of-care focused echocardiographic asystole as a predictive factor for absence of return of spontaneous circulatory in out-of-hospital cardiac arrests: a study protocol for a prospective, multicentre observational study. BMJ Open. 2019 Aug 30;9(8):e027448. doi: 10.1136/bmjopen-2018-027448.

    PubMed 31471433

Questions about this trial

What is this clinical trial studying?

An observational study of Prehospital Cardio-Respiratory Arrests and Spontaneous Circulatory Activity Recovery, run by Nantes University Hospital at 7 sites 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 1 inclusion and 1 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

Assess prognostic value of early echographic (ECCU) asystole (i.e. within the first 12 minutes of resuscitation) on resuscitation failure (absence of CRAR). (time frame: 1 month). 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 NCT03494153, which also lists 3 linked publications.

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 17 Apr 2026.

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