A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
LV Dysfunction; Valve Disease; PAH; and CHD
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System|
- True positive fractions (TPF) [ Time Frame: 2 years ] [ Designated as safety issue: No ]the true positive fractions (TPF) will be assessed between the physical examination and the Vscan examination using McNemar's test
- false positive fractions (FPF) [ Time Frame: 2 years ] [ Designated as safety issue: No ]false positive fractions (FPF) will be assessed between the Vscan and the physical examination
- Estimated False Positive Fractions [ Time Frame: 2 years ] [ Designated as safety issue: No ]False positive fractions will be assessed between the Vscan and the physical examination with separate estimates obtained for each of the four disease diagnoses
|Study Start Date:||February 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076296
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Sanjiv Kaul, MD||Oregon Health and Science University|