Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

NCT05631977 | Completed

• 1 other identifier: POC1
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 3

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.

Conditions

Diagnosis

Keywords

Point of care ultrasound; Echocardiography

Outcome Measures

Primary Outcomes (1)

• POCUS QUALITY

  Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard)

  1 month

Secondary Outcomes (1)

• Subgroup analysis

  1 month

Study Arms (1)

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

Interventions

Point of care ultrasound cardiac examination OTHER

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.

POCUS acquisition

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aisap LTD: lead

Study Sites (3)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Inova Health

Fairfax, Virginia, 22031, United States

Location

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 30, 2022
• Study Start: January 23, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IL (1)