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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is an "observational" study with no additional procedures or intervention prescribed other than using the Vscan along with a routine medical physical exam.
The study requires 2 visits to OHSU.
At the first visit a cardiac physical exam will be done by a cardiologist.
At a second visit, a different cardiologist will perform an ultrasound scan (as part of your standard of care) using a Vscan Ultrasound System. The first and the second visit may be done on the same day depending upon your schedule and if it's convenient for you to stay. The total exam time for both the visits, including standard exam and the study device exam will be about 45 minutes.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Correct Diagnosis | A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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In-patient and outpatient population of OHSU Division of Cardiovascular Medicine
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| Name | Affiliation | Role |
|---|---|---|
| Sanjiv Kaul, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abnormal Left Ventricle Function | Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality. |
| FG001 | Normal Left Ventricle Function | Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality. |
| FG002 | Abnormal Right Ventricle Function | Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality. |
| FG003 | Normal Right Ventricle Function | Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality. |
| FG004 | Pulmonary Hypertension | Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension. |
| FG005 | No Pulmonary Hypertension | Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension. |
| FG006 | Heart Valve Disease | Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD. |
| FG007 | No Heart Valve Disease | Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total for All Groups Assessed | Subjects assessed for LV function using both VScan and a clinical examination. |
| 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 | Percentage of Correct Diagnosis | A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard. | Posted | Number | 95% Confidence Interval | percentage of correct diagnosis | 2 years |
|
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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 | Abnormal Left Ventricle Function | Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anita Johnson | GE Healthcare | 262-548-2825 | Anita.Johnson@ge.com |
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| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| D018497 | Ventricular Dysfunction, Right |
| D006976 | Hypertension, Pulmonary |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Abnormal Right Ventricle Function |
Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality. |
| OG003 | Normal Right Ventricle Function | Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality. |
| OG004 | Pulmonary Hypertension | Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension. |
| OG005 | No Pulmonary Hypertension | Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension. |
| OG006 | Heart Valve Disease | Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD. |
| OG007 | No Heart Valve Disease | Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD. |
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Normal Left Ventricle Function | Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality. | 0 | 196 | 0 | 196 |
| EG002 | Abnormal Right Ventricle Function | Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality. | 0 | 51 | 0 | 51 |
| EG003 | Normal Right Ventricle Function | Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality. | 0 | 199 | 0 | 199 |
| EG004 | Pulmonary Hypertension | Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension. | 0 | 59 | 0 | 59 |
| EG005 | No Pulmonary Hypertension | Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension. | 0 | 191 | 0 | 191 |
| EG006 | Heart Valve Disease | Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD. | 0 | 51 | 0 | 51 |
| EG007 | No Heart Valve Disease | Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD. | 0 | 199 | 0 | 199 |
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| D012140 |
| Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |