Kosmos Trio and Ejection Fraction Pivotal Study

Completed

• Conditions: Cardiac Disease
• Interventions: Device: Portable Ultrasound System

• Registration Number: NCT06027164
• Lead Sponsor: EchoNous Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-27
• Study Start: 2023-08-04
• Primary Completion: 2023-08-31
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-07
• Status Verified: 2024-05
• Study Completion: 2024-05-16
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Subjects	Portable Ultrasound System	Ultrasound scans conducted by novice users and experts on this cohort.

Primary Outcome Measures

Name	Time	Method
Assessment of Right Ventricular Size	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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.
Assessment of Global Left Ventricular Function	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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.
Assessment of Left Ventricular Size	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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.
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	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of Automatic Structure Labelling	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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.
Manual vs. KOSMOS-EF for Sonographer Scans	Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments	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.
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	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.

Trial Locations

Locations (1)

Revival Research Institute LLC; 🇺🇸 Dearborn, Michigan, United States