Clinical trial NCT06027164: Kosmos Trio and Ejection Fraction Pivotal Study
Official title: Kosmos Trio and Ejection Fraction Pivotal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Lead sponsor: EchoNous Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
name: Revival Research Institute LLC
name: Centaur Labs
First posted: 2023-09-07
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Global Left Ventricular Function
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Assessment of Left Ventricular Size
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Assessment of Non-Trivial Pericardial Effusion
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Assessment of Right Ventricular Size
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Secondary outcomes:
measure: Assessment of Automatic Structure Labelling
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Manual vs. KOSMOS-EF for Sonographer Scans
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
measure: Assessment of Left Atrial Size
timeFrame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Revival Research Institute LLC
state: Michigan
Study officials:
References: