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To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | All participants to receive standard transthoracic echocardiogram and hand held echocardiogram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips EPIQ 7 ultrasound machine | Device | Standard transthoracic echocardiography |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Sokoloski, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | All participants to receive standard transthoracic echocardiogram and hand held echocardiogram Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | All participants to receive standard transthoracic echocardiogram and hand held echocardiogram Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography | Posted | Count of Participants | Participants | Day 1 |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | All participants to receive standard transthoracic echocardiogram and hand held echocardiogram Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Sokoloski | University of Miami | 305 585-6683 | msokoloski@med.miami.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2018 | May 22, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D010490 | Pericardial Effusion |
| D006343 | Heart Septal Defects |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| Philips Lumify Broadband sector array transducer |
| Device |
Portable hand-held ultrasound device |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| weight | Mean | Standard Deviation | kg |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |