Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06027164
Other study ID # ECHO-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 4, 2023
Est. completion date May 16, 2024

Study information

Verified date May 2024
Source EchoNous Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date May 16, 2024
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Portable Ultrasound System
EchoNous KOSMOS

Locations

Country Name City State
United States Revival Research Institute LLC Dearborn Michigan

Sponsors (4)

Lead Sponsor Collaborator
EchoNous Inc. Centaur Labs, Revival Research Institute LLC, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05490303 - HeartGuide: Preliminary Study N/A
Completed NCT05070819 - Atrial Natriuretic Peptide in Assessing Fluid Status N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04511403 - Prevalence of Oral Mucosal Alterations In a Sample of Egyptian Patients With Cardiovascular Diseases: A Hospital- Based Cross-Sectional Study
Completed NCT02697760 - The CZT Dynamic Myocardial Perfusion Imaging
Terminated NCT05157568 - Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation N/A
Not yet recruiting NCT04160845 - Non-invasive Forehead Skin Temperature in Cardiac Surgery
Completed NCT04500912 - Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population N/A
Not yet recruiting NCT06438159 - Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation. N/A
Recruiting NCT06154473 - Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit
Not yet recruiting NCT05877755 - Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging N/A
Completed NCT03394859 - Electronic Medical Records and Genomics (eMERGE) Phase III
Recruiting NCT05055830 - Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Recruiting NCT04374799 - Heparin vs Placebo for Cardiac Catheterization Phase 3
Completed NCT03174106 - Longterm Follow-up of Cardiac Patients With an Smartphone-Application N/A
Recruiting NCT05531253 - Respired Gases in Patients Post Cardiac Surgery
Recruiting NCT04609228 - Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors
Recruiting NCT06149143 - Cardiac Performance System Data Collection Study - Minnesota
Recruiting NCT05725655 - Hot Water Immersion After Myocardial Infarction N/A
Recruiting NCT06073509 - Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT