Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care

Conditions
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Diagnosis

Intervention / Treatment
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* Other: Point of care ultrasound cardiac examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POCUS acquisition<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POCUS QUALITY | Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subgroup analysis | 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. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Point of care ultrasound, Echocardiography