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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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Individuals under the care of the cardiology institutes of the participating sites, both inpatients and outpatient clinics and services.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States | ||
| Inova Health |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Fairfax |
| Virginia |
| 22031 |
| United States |
| Sheba Medical Center | Ramat Gan | Israel |