Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

Diagnosis Clinical Trial

— POCUS_ACQ  

Official title:

Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631977
• Other study ID #: POC1
• Status: Completed
• Start date: January 23, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Aisap LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis

Intervention

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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan
United States	Inova Health	Fairfax	Virginia
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Aisap LTD

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POCUS QUALITY	Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard)	1 month
Secondary	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