Study Stopped
low rate recruitment
Real Time Amplitude Spectrum Area to Guide Defibrillation
AMSA
AMplitude Spectrum Area to Guide Defibrillation During Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest Patients
1 other identifier
interventional
31
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 3, 2017
CompletedStudy Start
First participant enrolled
April 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2021
CompletedOctober 3, 2022
September 1, 2021
2.2 years
July 21, 2017
September 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Return of spontaneous circulation (ROSC)
Termination of ventricular fibrillation with achievement of ROSC for an AMSA value ≥ 15.5 mV-Hz
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
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
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
at 6 and 24 hours after ICU admission
Short term survival
at hospital admission and 24 hours after ROSC
Long term survival
at 1 and 6 months after ROSC
Study Arms (2)
AMSA-CPR
EXPERIMENTALThe professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator
Standard-CPR
ACTIVE COMPARATORThe defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines
Interventions
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
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)
chest compressions and ventilations at a rate of 30:2
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mario Negri Institute for Pharmacological Researchlead
- European Commissioncollaborator
- Zoll Medical Corporationcollaborator
Study Sites (2)
UOC Rianimazione-Emergenza Territoriale 118, Dipartimento di Emergenza, Ospedale Maggiore - AUSL di Bologna
Bologna, 40124, Italy
SOREU Metropolitana - AREU ASST, Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Related Publications (1)
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.
PMID: 36977371DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giuseppe Ristagno, MD, PhD
Istituto Di Ricerche Farmacologiche Mario Negri
- STUDY CHAIR
Roberto Latini, MD
Istituto Di Ricerche Farmacologiche Mario Negri
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2017
First Posted
August 3, 2017
Study Start
April 28, 2019
Primary Completion
July 26, 2021
Study Completion
July 26, 2021
Last Updated
October 3, 2022
Record last verified: 2021-09