POCUS_ACQ: Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

Sponsor

Aisap LTD (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05631977

Collaborator

(none)

300

Enrollment

Location

2.2

Anticipated Duration (Months)

134.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diagnosis	Other: Point of care ultrasound cardiac examination

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

Actual Study Start Date :

Jan 23, 2023

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba Medical Center	Ramat Gan		Israel

Sponsors and Collaborators

Aisap LTD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aisap LTD

ClinicalTrials.gov Identifier:

NCT05631977

Other Study ID Numbers:

POC1

First Posted:

Nov 30, 2022

Last Update Posted:

Feb 2, 2023

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aisap LTD

Point of care ultrasound

Echocardiography

Additional relevant MeSH terms:

Disease

Study Results

No Results Posted as of Feb 2, 2023