Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

Completed

• Conditions: Diagnosis
• Interventions: Other: Point of care ultrasound cardiac examination

• Registration Number: NCT05631977
• Lead Sponsor: Aisap LTD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-30
• Study Start: 2023-01-23
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POCUS acquisition	Point of care ultrasound cardiac examination	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.

Primary Outcome Measures

Name	Time	Method
POCUS QUALITY	1 month	Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard)

Secondary Outcome Measures

Name	Time	Method
Subgroup analysis	1 month	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.

Trial Locations

Locations (3)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Inova Health; 🇺🇸 Fairfax, Virginia, United States