NCT04906252

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
813

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

3.3 years

First QC Date

May 24, 2021

Last Update Submit

March 27, 2025

Conditions

Cardiac Arrest

Keywords

EchocardiographyUltrasoundVentricular FibrillationVfib

Outcome Measures

Primary Outcomes (2)

  • Survival to Hospital Admission

    Percentage of patients who survive at the point where they are admitted to the hospital

    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

    up to 60 minutes

Secondary Outcomes (3)

  • Return of Spontaneous Circulation (ROSC)

    up to 60 minutes

  • Survival to Hospital Discharge

    up to discharge, on average 7 days

  • Ventricular Fibrillation (VFib) detected via Ultrasound but not detected via Electrocardiogram (ECG)

    up to 60 minutes

Study Arms (3)

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.

Diagnostic Test: EchocardiographyDiagnostic 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

Diagnostic Test: EchocardiographyDiagnostic 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

Diagnostic Test: EchocardiographyDiagnostic Test: Electrocardiogram (ECG)

Interventions

EchocardiographyDIAGNOSTIC_TEST

Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution

Also known as: Ultrasound
Asystole Cardiac ArrestPEAVentricular Fibrillation
Electrocardiogram (ECG)DIAGNOSTIC_TEST

Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution

Asystole Cardiac ArrestPEAVentricular Fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting after out of hospital cardiac arrest to the emergency department.

You may qualify if:

  • Patients presenting in out-of-hospital, atraumatic cardiac arrest

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 02747, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Allegheny Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Univesity of Texas San Antonio

San Antonio, Texas, 78249, United States

Location

MeSH Terms

Conditions

Heart ArrestVentricular Fibrillation

Interventions

EchocardiographyUltrasonographyElectrocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularElectrodiagnosis

Study Officials

  • Romolo Gaspari, MD, PhD

    UMass Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 28, 2021

Study Start

September 15, 2021

Primary Completion

December 31, 2024

Study Completion

January 1, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

As a cardiac arrest study, there is not a current plan to share individual data but this may be reconsidered if required

Locations

US(6)