Kosmos Trio and Ejection Fraction Pivotal Study

This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis

Study Overview

• Status: Completed
• Conditions: Cardiac Disease
• Intervention / Treatment: Device: Portable Ultrasound System

• Study Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Revival Research Institute LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the Emergency Department Observation Unit (EDOU) will be eligible for enrollment. Patients admitted to the EDOU often spend a prolonged amount of time in the EDOU (often > 24 hours) awaiting further testing, therapies, or specialist consultations, thus recruiting from this pool of patients is most likely to allow for completion of study procedures without impacting the course of their clinical care

Description

Inclusion Criteria:

• Aged 18-89 years of age
• Have capacity to provide written consent either themselves or via healthcare proxy as determined by subjects' clinical care teams
• Have an anticipated timeline in the EDOU long enough to allow for completion of study procedures without causing delay to subjects' usual clinical care

Exclusion Criteria:

• Heart rate > 110 beats per minute at the time of recruitment
• Pregnant women
• Prior chest surgery
• Chest wall deformities or injuries (i.e. wounds, infections, etc)
• Limited mobility precluding them from turning in bed independently
• Speak a primary language other than English or Spanish
• Vulnerable populations including: patients being evaluated for psychiatric crises, incarcerated individuals
• Unwilling or unable to consent to study procedures

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Subjects; Ultrasound scans conducted by novice users and experts on this cohort.	Device: Portable Ultrasound System; EchoNous KOSMOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Global Left Ventricular Function	A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurses is of sufficient image quality to make a qualitative visual assessment of the Global Left Ventricular Function.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Left Ventricular Size	A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of the Left Ventricular Size.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Non-Trivial Pericardial Effusion	A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Non-Trivial Pericardial Effusion.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Right Ventricular Size	A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Right Ventricle Size.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Automatic Structure Labelling	A panel of cardiologists will access and determine via a majority vote if the frame-level false discovery rate (FDR) of automated cardiac structure labeling as determined by expert cardiologists for scans acquired by cardiac sonographers.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Manual vs. KOSMOS-EF for Sonographer Scans	Measurements are computed for A4C and A2C scans acquired by sonographers . We will compare KOSMOS-EF LVEF calculation to LVEF calculated by a panel of cardiologists via a majority vote.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Assessment of Left Atrial Size	A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Left Atrial Size.	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Collaborators and Investigators

• Sponsor: EchoNous Inc.
• Collaborators: University of California, San Francisco; Revival Research Institute LLC; Centaur Labs

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: ECHO-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes