Out-Of-Hospital Cardiac ArrestAMSANCT03237910
Real Time Amplitude Spectrum Area to Guide Defibrillation
A study testing AMSA, Defibrillation and CPR in people with Out-Of-Hospital Cardiac Arrest and Ventricular Fibrillation, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.
Trial summary
AMSA trial is a multicenter, randomized, controlled study in out-of-hospital cardiac arrest patients. The purpose of the study is to test the hypothesis that a real time AMSA analysis during CPR may predict the success of defibrillation and optimize the timing of defibrillation delivery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation
- What is being tested?
- AMSA, Defibrillation and CPR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesItaly
- Study dates
- 28 Apr 2019to 26 Jul 2021
- 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
- All adult patients (age ≥ 18) suffering of out-of-hospital non traumatic cardiac arrest of presumably cardiac etiology with a presenting shockable rhythm requiring electrical defibrillation: Ventricular Fibrillation and pulseless Ventricular Tachycardia.
Who cannot join
- age < 18 years old
- pregnancy
- cardiac arrest with a non-shockable rhythm (pulseless electrical activity and asystole)
- a defibrillation delivered by an AED prior to ALS arrival
- cardiac arrest of traumatic origin
- non-cardiac cause of cardiac arrest
Show all 10Show fewer
- presumable irreversible death or known terminal illness at the beginning of ALS
- clinical death
- participation in another clinical or device trial within the previous 30 days
- refused informed consent to the use of data.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
UOC Rianimazione-Emergenza Territoriale 118, Dipartimento di Emergenza, Ospedale Maggiore - AUSL di Bologna
Bologna, 40124
SOREU Metropolitana - AREU ASST, Grande Ospedale Metropolitano Niguarda
Milan, 20162
About this study
Official title: AMplitude Spectrum Area to Guide Defibrillation During Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest Patients
AMSA trial is a multicenter, randomized, controlled study in out-of-hospital cardiac arrest patients.
The purpose of the study is to test the hypothesis that a real time AMSA analysis during CPR may predict the success of defibrillation and optimize the timing of defibrillation delivery.
Read more
The primary end-point is the efficacy of the AMSA-CPR: termination of VF/VT with achievement of ROSC for an AMSA ≥ 15.5 mV-Hz
All patients meeting inclusion/exclusion criteria and receiving cardiopulmonary resuscitation are randomized into two groups: AMSA-guided CPR or standard CPR.
In the AMSA-CPR group, AMSA value suggests when the rescuer should deliver the defibrillation attempt; In the Standard-CPR group, the defibrillation is delivered based on the 2015 European Resuscitation Council (ERC) CPR guidelines.
Read the detailed description
In the AMSA-CPR intervention, upon arrival of the advanced life support (ALS) rescue team at the cardiac arrest scene and application of the defibrillatory pads to the patient's chest and power on of the defibrillator with the real time AMSA analysis:
- If AMSA is ≥ 15.5 mV-Hz, an immediate defibrillation is attempted, followed by CPR
- If AMSA is < 15.5 mV-Hz, defibrillation is not attempted and CPR is delivered
- During the 2-min cycle of CPR, AMSA is measured during pauses for ventilations (every 30 CC, approximately every 20/25 sec). If an AMSA value ≥ 15.5 mV-Hz is achieved prior to cycle completion, an immediate defibrillation is delivered (thus the defibrillation attempt is anticipated)
After completion of the first 2-min CPR cycle:
- If AMSA is ≤ 6.5 mV-Hz, the defibrillation is not attempted but CPR is continued
- If AMSA is > 6.5 mV-Hz, an immediate defibrillation attempt is delivered, followed by CPR
- During the 2-min cycle of CPR, AMSA is measured during pauses for ventilations (every 30 CC, approximately every 20/25 sec). If an AMSA value ≥ 15.5 mV-Hz is achieved prior to cycle completion, an immediate defibrillation is delivered
After completion of the second 2-min CPR cycle and till the end of the resuscitative intervention:
- CPR is continued based on standard 2015 ERC guidelines (a defibrillation attempt every 2-min CPR cycles), except for the possibility to anticipate the defibrillation attempt if AMSA becomes ≥ 15.5 mV-Hz during the CPR cycle.
In the standard CPR intervention, upon arrival of the ALS team at the cardiac arrest scene, and application of the defibrillatory pads to the patient's chest and power on of the defibrillator:
- a defibrillation is immediately attempted and CPR is then started and continued for 2- min. Analysis of rhythm and subsequent defibrillation attempts are performed every 2-min CPR cycles.
In both study groups, the quality of CC and ventilation is monitored in real time thought the feedback integrated into the defibrillator.
- Being tested
- AMSA, Defibrillation, CPR
- Keywords
- amplitude spectrum area, defibrillation, waveform analysis, cardiopulmonary resuscitation, cardiac arrest
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Ventricular Fibrillation, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMSADiagnostic test
Also called VF waveform analysis
A non-invasive and real time VF (Amplitude Spectrum Area) AMSA analysis is performed during chest compression pauses for delivery of 2 ventilations, from the ECG acquired from the conventional defibrillatory pads
DefibrillationProcedure or surgery
Also called electric countershock
delivery of the defibrillation is attempted to terminate VF either based on AMSA value (in the AMSA-CPR arm) or every 2-min CPR cycle as recommended by current guidelines (in the Standard-CPR arm)
CPRProcedure or surgery
Also called resuscitation maneuvres
chest compressions and ventilations at a rate of 30:2
| Study group | Role | What they receive |
|---|---|---|
| AMSA-CPR | Experimental | The professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator Receives: Diagnostic Test: AMSA; Procedure: Defibrillation; Procedure: CPR |
| Standard-CPR | Active comparator | The defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines Receives: Procedure: Defibrillation; Procedure: CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of spontaneous circulation (ROSC)
Termination of ventricular fibrillation with achievement of ROSC for an AMSA value ≥ 15.5 mV-Hz
Measured: At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first)
Secondary outcomes (5)
Defibrillation attempts
Number of defibrillations to achieve ROSC
Measured: At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first)
CPR duration
duration of CPR in minutes prior to achieve ROSC
Measured: At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first)
Cardiac troponins
assessment of circulating levels of high sensitive cardiac troponin T in plasma as marker of cardiac injury
Measured: at 6 and 24 hours after ICU admission
Short term survival
number of patients alive after initial resuscitation
Measured: at hospital admission and 24 hours after ROSC
Long term survival
number of patients alive after initial resuscitation
Measured: at 1 and 6 months after ROSC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start28 Apr 2019
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Why it stopped: low rate recruitment
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Zoll Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Giuseppe Ristagno, MD, PhD, Study chair, Istituto Di Ricerche Farmacologiche Mario NegriRoberto Latini, MD, Study chair, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237910
- Sponsor's protocol ID
- IRFMN-7167-7429
- Acronym
- AMSA
- Status last verified
- Sep 2021
- First submitted
- 21 Jul 2017
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ruggeri L, Fumagalli F, Bernasconi F, Semeraro F, Meessen JMTA, Blanda A, Migliari M, Magliocca A, Gordini G, Fumagalli R, Sechi G, Pesenti A, Skrifvars MB, Li Y, Latini R, Wik L, Ristagno G. Amplitude Spectrum Area of ventricular fibrillation to guide defibrillation: a small open-label, pseudo-randomized controlled multicenter trial. EBioMedicine. 2023 Apr;90:104544. doi: 10.1016/j.ebiom.2023.104544. Epub 2023 Mar 26.
PubMed 36977371
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMplitude Spectrum Area to Guide Defibrillation During Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest Patients
- ClinicalTrials.gov ID
- NCT03237910
- Acronym / sponsor ID
- AMSA / IRFMN-7167-7429
- Keywords
- amplitude spectrum area, defibrillation, waveform analysis, cardiopulmonary resuscitation, cardiac arrest
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low rate recruitment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- European Commission, Zoll Medical Corporation
- Study start
- 28 Apr 2019 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 3 Aug 2017 (actual)
- 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.
AMSA trial is a multicenter, randomized, controlled study in out-of-hospital cardiac arrest patients.
The purpose of the study is to test the hypothesis that a real time AMSA analysis during CPR may predict the success of defibrillation and optimize the timing of defibrillation delivery.
The primary end-point is the efficacy of the AMSA-CPR: termination of VF/VT with achievement of ROSC for an AMSA ≥ 15.5 mV-Hz
All patients meeting inclusion/exclusion criteria and receiving cardiopulmonary resuscitation are randomized into two groups: AMSA-guided CPR or standard CPR.
In the AMSA-CPR group, AMSA value suggests when the rescuer should deliver the defibrillation attempt; In the Standard-CPR group, the defibrillation is delivered based on the 2015 European Resuscitation Council (ERC) CPR guidelines.
Detailed description
In the AMSA-CPR intervention, upon arrival of the advanced life support (ALS) rescue team at the cardiac arrest scene and application of the defibrillatory pads to the patient's chest and power on of the defibrillator with the real time AMSA analysis:
- If AMSA is ≥ 15.5 mV-Hz, an immediate defibrillation is attempted, followed by CPR
- If AMSA is < 15.5 mV-Hz, defibrillation is not attempted and CPR is delivered
- During the 2-min cycle of CPR, AMSA is measured during pauses for ventilations (every 30 CC, approximately every 20/25 sec). If an AMSA value ≥ 15.5 mV-Hz is achieved prior to cycle completion, an immediate defibrillation is delivered (thus the defibrillation attempt is anticipated)
After completion of the first 2-min CPR cycle:
- If AMSA is ≤ 6.5 mV-Hz, the defibrillation is not attempted but CPR is continued
- If AMSA is > 6.5 mV-Hz, an immediate defibrillation attempt is delivered, followed by CPR
- During the 2-min cycle of CPR, AMSA is measured during pauses for ventilations (every 30 CC, approximately every 20/25 sec). If an AMSA value ≥ 15.5 mV-Hz is achieved prior to cycle completion, an immediate defibrillation is delivered
After completion of the second 2-min CPR cycle and till the end of the resuscitative intervention:
- CPR is continued based on standard 2015 ERC guidelines (a defibrillation attempt every 2-min CPR cycles), except for the possibility to anticipate the defibrillation attempt if AMSA becomes ≥ 15.5 mV-Hz during the CPR cycle.
In the standard CPR intervention, upon arrival of the ALS team at the cardiac arrest scene, and application of the defibrillatory pads to the patient's chest and power on of the defibrillator:
- a defibrillation is immediately attempted and CPR is then started and continued for 2- min. Analysis of rhythm and subsequent defibrillation attempts are performed every 2-min CPR cycles.
In both study groups, the quality of CC and ventilation is monitored in real time thought the feedback integrated into the defibrillator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMSA-CPR | Experimental | Diagnostic Test: AMSA, Procedure: Defibrillation, Procedure: CPRThe professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator |
| Standard-CPR | Active comparator | Procedure: Defibrillation, Procedure: CPRThe defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (age ≥ 18) suffering of out-of-hospital non traumatic cardiac arrest of presumably cardiac etiology with a presenting shockable rhythm requiring electrical defibrillation: Ventricular Fibrillation and pulseless Ventricular Tachycardia.
Key exclusion criteria (10 listed)
- age < 18 years old
- pregnancy
- cardiac arrest with a non-shockable rhythm (pulseless electrical activity and asystole)
- a defibrillation delivered by an AED prior to ALS arrival
- cardiac arrest of traumatic origin
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 |
|---|---|---|
| AMSAAlso: VF waveform analysisA non-invasive and real time VF (Amplitude Spectrum Area) AMSA analysis is performed during chest compression pauses for delivery of 2 ventilations, from the ECG acquired from the conventional defibrillatory pads | Diagnostic test | AMSA-CPR |
| DefibrillationAlso: electric countershockdelivery of the defibrillation is attempted to terminate VF either based on AMSA value (in the AMSA-CPR arm) or every 2-min CPR cycle as recommended by current guidelines (in the Standard-CPR arm) | Procedure or surgery | AMSA-CPR, Standard-CPR |
| CPRAlso: resuscitation maneuvreschest compressions and ventilations at a rate of 30:2 | Procedure or surgery | AMSA-CPR, Standard-CPR |
Primary outcome
Return of spontaneous circulation (ROSC)
Time frame: At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first)
Termination of ventricular fibrillation with achievement of ROSC for an AMSA value ≥ 15.5 mV-Hz
5 secondary outcomes
Defibrillation attempts
Time frame: At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first)
CPR duration
Time frame: At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first)
Cardiac troponins
Time frame: at 6 and 24 hours after ICU admission
Short term survival
Time frame: at hospital admission and 24 hours after ROSC
Long term survival
Time frame: at 1 and 6 months after ROSC
Results and safety
The study was stopped early (reason given: low rate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 36977371Ruggeri L, Fumagalli F, Bernasconi F, Semeraro F, Meessen JMTA, Blanda A, Migliari M, Magliocca A, Gordini G, Fumagalli R, Sechi G, Pesenti A, Skrifvars MB, Li Y, Latini R, Wik L, Ristagno G. Amplitude Spectrum Area of ventricular fibrillation to guide defibrillation: a small open-label, pseudo-randomized controlled multicenter trial. EBioMedicine. 2023 Apr;90:104544. doi: 10.1016/j.ebiom.2023.104544. Epub 2023 Mar 26.
- EU Framework Horizon 2020 Programme under grant agreement no. 733381: European Sudden Cardiac Arrest network: towards Prevention, Education and New Treatment (ESCAPE-NET)Link provided by the sponsor.
- ESCAPE NET in ERC websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Out-Of-Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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.
Giuseppe Ristagno, MD, PhD study chair
Istituto Di Ricerche Farmacologiche Mario Negri
Roberto Latini, MD study chair
Istituto Di Ricerche Farmacologiche Mario Negri
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMSA, Defibrillation and CPR in people with Out-Of-Hospital Cardiac Arrest and Ventricular Fibrillation, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.
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 10 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: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 was stopped early (reason given: low rate recruitment). Results are not available in the source record.
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?
Return of spontaneous circulation (ROSC) (time frame: At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first)). 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 NCT03237910, 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 3 Oct 2022.