Heart Valve Diseases, Left Ventricular Dysfunction, Pulmonary Hypertension, Right Ventricular Dysfunction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Oregon Health and Science University
GE Healthcare
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * provided signed and dated informed consent and is willing to provide GE Healthcare with demographic data, cardiac medical history, information collected as part of the study * New patients who have an echocardiogram less than 6 months and patients who will be undergoing an echocardiogram as part of their routine clinical care
Exclusion criteria
* Pregnant * less than 18 years of age. * unwilling to provide informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Correct Diagnosis | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total for All Groups Assessed Subjects assessed for LV function using both VScan and a clinical examination. | 1,000 |
| Total | 1,000 |
Baseline characteristics
| Characteristic | Total for All Groups Assessed |
|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 15.4 |
| Sex: Female, Male Female | 656 Participants |
| Sex: Female, Male Male | 344 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 196 | 0 / 51 | 0 / 199 | 0 / 59 | 0 / 191 | 0 / 51 | 0 / 199 |
| serious Total, serious adverse events | 0 / 54 | 0 / 196 | 0 / 51 | 0 / 199 | 0 / 59 | 0 / 191 | 0 / 51 | 0 / 199 |
Outcome results
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abnormal Left Ventricle Function | Percentage of Correct Diagnosis | 61 percentage of correct diagnosis |
| Normal Left Ventricle Function | Percentage of Correct Diagnosis | 31 percentage of correct diagnosis |
| Abnormal Right Ventricle Function | Percentage of Correct Diagnosis | 47 percentage of correct diagnosis |
| Normal Right Ventricle Function | Percentage of Correct Diagnosis | 6 percentage of correct diagnosis |
| Pulmonary Hypertension | Percentage of Correct Diagnosis | 10 percentage of correct diagnosis |
| No Pulmonary Hypertension | Percentage of Correct Diagnosis | 3 percentage of correct diagnosis |
| Heart Valve Disease | Percentage of Correct Diagnosis | 39 percentage of correct diagnosis |
| No Heart Valve Disease | Percentage of Correct Diagnosis | 4 percentage of correct diagnosis |