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NCT05631977
Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care
Conditions: Diagnosis
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: 1
Enrollment: 300
Sponsor: Aisap LTD
Location: Israel
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.
Eligibility Criteria
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 formStated willingness to comply with all study procedures and availability for the duration of the studyMale or female, aged 21 or moreExclusion 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 judgmentPresence of prosthetic cardiac valve at any position and any typePregnancy or lactationContact isolation due to infections diseasePresence of left ventricular assist device (LVAD)Know existence of congenital heart diseaseProsthetic cardiac valve, anyBMI 40 or greaterClinical conditions that do not permit a POCUS study according to the judgment of the investigators or treating physiciansHistory of lung resectionKnown poor cardiac US image quality based on prior echo examsMechanical ventilation, or other situations where the required ultrasound views cannot be adequately obtainedClinical instability or critical subject condition or any condition the study PI judges that the POCUS exam could adversely affect the participant
Source: ClinicalTrials.gov (NCT05631977). StuddyBuddy aggregates publicly available trial information.