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Completed

NCT Number: NCT06027164

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

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Revival Research Institute LLC

Dearborn, Michigan, 48126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Portable Ultrasound System

Device

EchoNous KOSMOS

Primary outcomes

  1. Assessment of Global Left Ventricular Function

    Time frame: 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.

  2. Assessment of Left Ventricular Size

    Time frame: 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.

  3. Assessment of Non-Trivial Pericardial Effusion

    Time frame: 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.

  4. Assessment of Right Ventricular Size

    Time frame: 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.

Secondary outcomes

  1. Assessment of Automatic Structure Labelling

    Time frame: 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.

  2. Manual vs. KOSMOS-EF for Sonographer Scans

    Time frame: 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.

  3. Assessment of Left Atrial Size

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

EchoNous Inc.

Industry

Collaborators

  • Centaur Labs
  • Revival Research Institute LLC
  • University of California, San Francisco

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 7, 2023
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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