Cardiac ArrestREASON3-2021NCT04906252
Vfib by ECG or Echo During Cardiac Arrest
An observational study of Cardiac Arrest, run by Romolo Gaspari at 6 sites in United States.
Trial summary
The goal of this study is to measure survival rates associated with patients presenting in cardiac arrest based on their electrocardiographic rhythm and their echocardiographic rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Echocardiography and Electrocardiogram (ECG)
- How many people
- 813 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Sep 2021to 1 Jan 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting after out of hospital cardiac arrest to the emergency department.
Who may be able to join
- Patients presenting in out-of-hospital, atraumatic cardiac arrest
Who cannot join
- Resuscitation ended due to end of life decisions
- Documented allergy to ultrasound gel
- Technical malfunction of ultrasound machine during imaging that prevents use Ultrasound machine unable to record images
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Duke University
Durham, North Carolina, 27710
Hartford Hospital
Hartford, Connecticut, 06106
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 02747
Allegheny Hospital
Pittsburgh, Pennsylvania, 15212
Univesity of Texas San Antonio
San Antonio, Texas, 78249
Stony Brook University
Stony Brook, New York, 11794
About this study
Official title: Ventricular Fibrillation and Electrocardiographic Rhythm vs Echocardiographic Rhythm During Cardiac Arrest
The goal of this study is to measure survival rates associated with patients presenting in cardiac arrest based on their electrocardiographic rhythm and their echocardiographic rhythm. Electrocardiographic rhythm is defined as the rhythm on the ECG and echocardiographic rhythm is the rhythm visualized on bedside ultrasound. Specifically, we will categorize patients based on identical rhythms and dichotomous rhythms with an interest in outcomes in the patient group where their echocardiographic and electrographic rhythms do not match. This is important as current ACLS protocols use electrocardiographic rhythms to determine therapy but limited research implies that therapeutic decisions based on echocardiographic rhythm may produce increased survival.
This study will occur during emergency department resuscitation of patients presenting in cardiac arrest. Patients presenting to the emergency department after cardiac arrest will undergo standard resuscitation based on ACLS protocols. Ultrasound imaging will be performed as soon as possible after the patient arrives and digitally recorded, as is currently the standard of care at the institute. Simultaneous recording of the ECG rhythm strip will occur as well. This will be repeated for as many pauses in CPR as is warranted.
Each site will record data based on the Utstein nomenclature including patient demographics, arrest details and survival outcomes. Ultrasound images and ECG recordings will be de-identified and submitted to a central database. Data will be uploaded into a centralized database. Statistical analysis will analyze outcomes based on echocardiographic and sonographic findings. Our aim is to measure the survival benefit of treating out of hospital cardiac arrest using echocardiographic rhythm instead of electrocardiographic rhythm.
Read the detailed description
This is a multi-center, prospective, observational trial involving sites across the United States and Canada. Patients will be enrolled through the emergency department either presenting in cardiac arrest, or going into cardiac arrest while in the emergency department after having arrested out of hospital. Advanced Cardiac Life Support (ACLS) protocols and institutional policies for resuscitation will be followed, as is the current standard of care. A patient encounter will conclude upon halting of cardiopulmonary resuscitation. Patient outcome will be evaluated by chart review or follow-up.
Programs involved in this study must have already integrated echocardiography into Cardiac Arrest clinically and have established procedures for how imaging is performed in the context of CPR. Echocardiography will not hinder or impair resuscitative efforts in any way, including halting CPR or prolonging pauses in CPR. Sonographic images will be obtained during designated pauses in chest compressions, as is routine care, during CPR for pulse checks, rhythm checks, and necessary resuscitative procedures.
Echocardiography will be performed as appropriate to obtain diagnostic information for each particular patient during resuscitative efforts. Recording of the image loops will be performed during image acquisition according to standard technology availability and clinical protocols at each site. To facilitate image acquisition, the ultrasound probe may be placed in the epigastrium or parasternal region during CPR with the heart centered in the field of view, if it will not interfere with ongoing resuscitation. Recording of the images can begin immediately upon pauses of CPR using whatever means are available at the site. Sonographic images will be obtained by competent personnel with experience in bedside cardiac ultrasound. This information will be made available to the physician taking care of the patient.
Continuous ECG tracings are displayed during cardiac arrest, and for the purpose of this study recordings of these ECG tracings will need to be digitally recorded. These digital ECG 'rhythm strips" will be matched with contemporaneous recordings of the ultrasound images of the heart.
Subject data, with identifiers removed, will be uploaded into the REDcap web-based database. Data will be obtained from initial patient encounter, patient records, and EMS records when available.
Contemporaneous digital recordings of ultrasound images and ECG rhythm strips blinded to patient identifiers will be included in a centralized database. Echocardiographic images will be reviewed and interpreted by the central coordinating site blinded to patient information. ECG images will be reviewed and interpreted by the central coordinating site blinded to patient information.
Patient cohorts will be compared for the electrical activity by ECG and the myocardial activity by echo.
- Conditions
- Cardiac Arrest
- Being tested
- Echocardiography, Electrocardiogram (ECG)
- Keywords
- Echocardiography, Ultrasound, Ventricular Fibrillation, Vfib
- Medical subject headings
- Heart Arrest, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Also called Ultrasound
Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution
Electrocardiogram (ECG)Diagnostic test
Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution
| Study group | Role | What they receive |
|---|---|---|
| Ventricular Fibrillation | Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Ventricular Fibrillation (Vfib) Cardiac Arrest or Patients demonstrating Vfib during cardiac arrest. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram (ECG) | |
| PEA | Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Pulseless Electrical Activity (PEA) Cardiac Arrest. Patients demonstrating PEA during cardiac arrest Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram (ECG) | |
| Asystole Cardiac Arrest | Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Asystolic Cardiac Arrest. Patients demonstrating Asystole during cardiac arrest Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram (ECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to Hospital Admission
Percentage of patients who survive at the point where they are admitted to the hospital
Measured: up to 60 minutes
Rhythm Change post defibrillation
Percentage of patients who when defibrillated have a change in their cardiac rhythm as reflected by Electrocardiogram (ECG) report
Measured: up to 60 minutes
Secondary outcomes (3)
Return of Spontaneous Circulation (ROSC)
Percentage of patients who demonstrate return of spontaneous circulation (ROSC)
Measured: up to 60 minutes
Survival to Hospital Discharge
Percentage of patients who survive at the point where they are discharged from the hospital
Measured: up to discharge, on average 7 days
Ventricular Fibrillation (VFib) detected via Ultrasound but not detected via Electrocardiogram (ECG)
The percentage of patients with Ventricular Fibrillation (VFib)which is detected via ultrasound examination but is not detected via Electrocardiogram (ECG)
Measured: up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start15 Sep 2021
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romolo Gaspari
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, Stony Brook University, University of Ottawa, ChristianaCare, Boston Medical Center, Dartmouth College, University of Alabama at Birmingham, University of Rochester, Baystate Medical Center, Medical College of Wisconsin, University of Pennsylvania, Prisma Health-Midlands, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Staten Island University Hospital, State University of New York - Upstate Medical University, University of Manitoba, Mayo Clinic, Kaweah Delta Health Care District, SBH Health System, Yale University, Johns Hopkins University, The University of Texas at San Antonio, Wake Forest University Health Sciences, University of Arkansas, Valleywise Health, Kendall Healthcare Group, Ltd., Truman Medical Center, Oregon Health and Science University, Vassar Brothers Medical Center, Brookdale University Hospital Medical Center, University of Kansas Medical Center, University of Maine, University of Colorado, Denver, Duke University, University at Buffalo, North Shore University Hospital, Hartford Hospital, Louisiana State University Health Sciences Center in New Orleans, University of Florida, University of Maryland, Sutter Medical Foundation, Arizona School of Health Sciences, Virginia Commonwealth University
- Responsible party
- Sponsor-investigator, Romolo Gaspari, University of Massachusetts, Worcester
- Investigators
- Romolo Gaspari, MD, PhD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906252
- Sponsor's protocol ID
- H00021832
- Acronym
- REASON3-2021
- Status last verified
- Mar 2025
- First submitted
- 24 May 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As a cardiac arrest study, there is not a current plan to share individual data but this may be reconsidered if required
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Fibrillation and Electrocardiographic Rhythm vs Echocardiographic Rhythm During Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04906252
- Acronym / sponsor ID
- REASON3-2021 / H00021832
- Conditions
- Cardiac Arrest
- Keywords
- Echocardiography, Ultrasound, Ventricular Fibrillation, Vfib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 813 participants (actual)
- Lead sponsor
- Romolo GaspariUniversity, hospital or other
- Collaborators
- Temple University, Stony Brook University, University of Ottawa, ChristianaCare, Boston Medical Center, Dartmouth College, University of Alabama at Birmingham, University of Rochester, Baystate Medical Center, Medical College of Wisconsin, University of Pennsylvania, Prisma Health-Midlands, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Staten Island University Hospital, State University of New York - Upstate Medical University, University of Manitoba, Mayo Clinic, Kaweah Delta Health Care District, SBH Health System, Yale University, Johns Hopkins University, The University of Texas at San Antonio, Wake Forest University Health Sciences, University of Arkansas, Valleywise Health, Kendall Healthcare Group, Ltd., Truman Medical Center, Oregon Health and Science University, Vassar Brothers Medical Center, Brookdale University Hospital Medical Center, University of Kansas Medical Center, University of Maine, University of Colorado, Denver, Duke University, University at Buffalo, North Shore University Hospital, Hartford Hospital, Louisiana State University Health Sciences Center in New Orleans, University of Florida, University of Maryland, Sutter Medical Foundation, Arizona School of Health Sciences, Virginia Commonwealth University
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 28 May 2021 (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.
The goal of this study is to measure survival rates associated with patients presenting in cardiac arrest based on their electrocardiographic rhythm and their echocardiographic rhythm. Electrocardiographic rhythm is defined as the rhythm on the ECG and echocardiographic rhythm is the rhythm visualized on bedside ultrasound. Specifically, we will categorize patients based on identical rhythms and dichotomous rhythms with an interest in outcomes in the patient group where their echocardiographic and electrographic rhythms do not match. This is important as current ACLS protocols use electrocardiographic rhythms to determine therapy but limited research implies that therapeutic decisions based on echocardiographic rhythm may produce increased survival.
This study will occur during emergency department resuscitation of patients presenting in cardiac arrest. Patients presenting to the emergency department after cardiac arrest will undergo standard resuscitation based on ACLS protocols. Ultrasound imaging will be performed as soon as possible after the patient arrives and digitally recorded, as is currently the standard of care at the institute. Simultaneous recording of the ECG rhythm strip will occur as well. This will be repeated for as many pauses in CPR as is warranted.
Each site will record data based on the Utstein nomenclature including patient demographics, arrest details and survival outcomes. Ultrasound images and ECG recordings will be de-identified and submitted to a central database. Data will be uploaded into a centralized database. Statistical analysis will analyze outcomes based on echocardiographic and sonographic findings. Our aim is to measure the survival benefit of treating out of hospital cardiac arrest using echocardiographic rhythm instead of electrocardiographic rhythm.
Detailed description
This is a multi-center, prospective, observational trial involving sites across the United States and Canada. Patients will be enrolled through the emergency department either presenting in cardiac arrest, or going into cardiac arrest while in the emergency department after having arrested out of hospital. Advanced Cardiac Life Support (ACLS) protocols and institutional policies for resuscitation will be followed, as is the current standard of care. A patient encounter will conclude upon halting of cardiopulmonary resuscitation. Patient outcome will be evaluated by chart review or follow-up.
Programs involved in this study must have already integrated echocardiography into Cardiac Arrest clinically and have established procedures for how imaging is performed in the context of CPR. Echocardiography will not hinder or impair resuscitative efforts in any way, including halting CPR or prolonging pauses in CPR. Sonographic images will be obtained during designated pauses in chest compressions, as is routine care, during CPR for pulse checks, rhythm checks, and necessary resuscitative procedures.
Echocardiography will be performed as appropriate to obtain diagnostic information for each particular patient during resuscitative efforts. Recording of the image loops will be performed during image acquisition according to standard technology availability and clinical protocols at each site. To facilitate image acquisition, the ultrasound probe may be placed in the epigastrium or parasternal region during CPR with the heart centered in the field of view, if it will not interfere with ongoing resuscitation. Recording of the images can begin immediately upon pauses of CPR using whatever means are available at the site. Sonographic images will be obtained by competent personnel with experience in bedside cardiac ultrasound. This information will be made available to the physician taking care of the patient.
Continuous ECG tracings are displayed during cardiac arrest, and for the purpose of this study recordings of these ECG tracings will need to be digitally recorded. These digital ECG 'rhythm strips" will be matched with contemporaneous recordings of the ultrasound images of the heart.
Subject data, with identifiers removed, will be uploaded into the REDcap web-based database. Data will be obtained from initial patient encounter, patient records, and EMS records when available.
Contemporaneous digital recordings of ultrasound images and ECG rhythm strips blinded to patient identifiers will be included in a centralized database. Echocardiographic images will be reviewed and interpreted by the central coordinating site blinded to patient information. ECG images will be reviewed and interpreted by the central coordinating site blinded to patient information.
Patient cohorts will be compared for the electrical activity by ECG and the myocardial activity by echo.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ventricular Fibrillation | – | Diagnostic Test: Echocardiography, Diagnostic Test: Electrocardiogram (ECG)Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Ventricular Fibrillation (Vfib) Cardiac Arrest or Patients demonstrating Vfib during cardiac arrest. |
| PEA | – | Diagnostic Test: Echocardiography, Diagnostic Test: Electrocardiogram (ECG)Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Pulseless Electrical Activity (PEA) Cardiac Arrest. Patients demonstrating PEA during cardiac arrest |
| Asystole Cardiac Arrest | – | Diagnostic Test: Echocardiography, Diagnostic Test: Electrocardiogram (ECG)Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Asystolic Cardiac Arrest. Patients demonstrating Asystole during cardiac arrest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting after out of hospital cardiac arrest to the emergency department.
Key inclusion criteria (1 listed)
- Patients presenting in out-of-hospital, atraumatic cardiac arrest
Key exclusion criteria (3 listed)
- Resuscitation ended due to end of life decisions
- Documented allergy to ultrasound gel
- Technical malfunction of ultrasound machine during imaging that prevents use Ultrasound machine unable to record images
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 |
|---|---|---|
| EchocardiographyAlso: UltrasoundPatients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution | Diagnostic test | Asystole Cardiac Arrest, PEA, Ventricular Fibrillation |
| Electrocardiogram (ECG)Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution | Diagnostic test | Asystole Cardiac Arrest, PEA, Ventricular Fibrillation |
Primary outcome
Survival to Hospital Admission
Time frame: up to 60 minutes
Percentage of patients who survive at the point where they are admitted to the hospital
Rhythm Change post defibrillation
Time frame: up to 60 minutes
Percentage of patients who when defibrillated have a change in their cardiac rhythm as reflected by Electrocardiogram (ECG) report
3 secondary outcomes
Return of Spontaneous Circulation (ROSC)
Time frame: up to 60 minutes
Survival to Hospital Discharge
Time frame: up to discharge, on average 7 days
Ventricular Fibrillation (VFib) detected via Ultrasound but not detected via Electrocardiogram (ECG)
Time frame: up to 60 minutes
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 2 Apr 2025.
- Individual participant dataSharing planned: No. As a cardiac arrest study, there is not a current plan to share individual data but this may be reconsidered if required
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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.
Romolo Gaspari, MD, PhD principal investigator
UMass Medical School
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Romolo Gaspari at 6 sites in United States.
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 3 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 to Hospital Admission (time frame: up to 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2025.