Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care (POCUS_ACQ)

The present study is a preparatory step towards a multi-reader multi case (MRMC) randomized fully crossed study. As POCUS images are frequently not stored and not methodically acquired using a standardized image acquisition protocol this study will collect cardiac POCUS images in a prespecified manner.

Study Overview

• Status: Completed
• Conditions: Diagnosis
• Intervention / Treatment: Other: Point of care ultrasound cardiac examination

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • INOVA Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Individuals under the care of the cardiology institutes of the participating sites, both inpatients and outpatient clinics and services.

Description

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 21 or more

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unstable clinical condition according to PI clinical judgment
2. Presence of prosthetic cardiac valve at any position and any type
3. Pregnancy or lactation
4. Contact isolation due to infections disease
5. Presence of left ventricular assist device (LVAD)
6. Know existence of congenital heart disease
7. Prosthetic cardiac valve, any
8. BMI 40 or greater
9. Clinical conditions that do not permit a POCUS study according to the judgment of the investigators or treating physicians
10. History of lung resection
11. Known poor cardiac US image quality based on prior echo exams
12. Mechanical ventilation, or other situations where the required ultrasound views cannot be adequately obtained
13. Clinical instability or critical subject condition or any condition the study PI judges that the POCUS exam could adversely affect the participant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

POCUS acquisition; Prospective noninterventional single arm study collection of cardiac POCUS examination according to prespecified acquisition protocol. Alongside POCUS images the study will also collect demographic and clinical information from the study participants and some information from the healthcare personal performing the POCUS exam (experience in US image acquisition, physician specialty or sonographer). Patient management will not be impacted, and usual care will follow the regular practices at the study site.

Other: Point of care ultrasound cardiac examination; The study intervention consists of a POCUS cardiac examination by site approved personal using an FDA cleared US scanner. Usual care of study participants will not be impacted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POCUS QUALITY	Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup analysis	Analysis of primary endpoint (POCUS exam quality) by the prespecified subgroups of age (above or below 65), gender, BMI group (below or above 25) and US device manufacturer.	1 month

Collaborators and Investigators

• Sponsor: Aisap LTD

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Echocardiography; Point of care ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: POC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No