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OpenTrials
Completed

NCT Number: NCT05631977

Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

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.

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Key information

Conditions

Diagnosis Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheba Medical Center, Ramat Gan, Israel

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. POCUS QUALITY

    Time frame: 1 month

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

Secondary outcomes

  1. Subgroup analysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aisap LTD

Industry

Registry information

Acronym: POCUS_ACQ

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2022
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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