Acute Coronary Syndrome, Congenital Heart Disease, Congestive Heart Failure, Pulmonary Embolism, Pulmonary Hypertension, Valvular Heart Disease
Conditions
Brief summary
The primary purpose of this study is to evaluate the diagnostic performance of three methods for measuring right ventricular size and function including the Philips Novel RV quantification technologies (RV Heart Model volumetric analysis and Philips 2D strain) and the Upper Valley Right Ventricle Algorithm (UVRV) algorithm as compared to the gold standard of volumetric analysis via cardiac magnetic resonance imaging (CMR) in a broad patient population.
Detailed description
This is a single-center, blinded, randomized control trial of patients 18-years or older that are undergoing CMR as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH. After informed consent is obtained, subjects undergo a study-specific external, non-invasive echocardiogram utilizing a special RV focused protocol on the same day of their CMR as close to their scheduled CMR as possible to minimize wait time for consented patients. The echocardiogram takes approximately an additional 30 minutes of the subject's time. De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three different methodologies (standard method, Phillips Novel technology and the newly developed UVRV algorithm). The methodologies will be compared with each other to determine sensitivity, specificity and accuracy.
Interventions
DIAGNOSTIC_TESTMeasuring Right Ventricular Size and Function
This study focuses on evaluating different approaches to evaluation of right ventricular size and function using the Upper Valley Right Ventricle Algorithm and novel imaging modalities
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age is over 18 years * Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric analysis * Patient is capable of giving informed consent * The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes
Exclusion criteria
\- Patient unable to under echocardiogram
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic measurement - Right ventricular size | Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour | De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Specific evaluating MRI derived right ventricular volumes versus various echo approaches to grading right ventricular size. |
| Echocardiographic measurement - Right ventricular function | Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour | De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. |
| Echocardiographic measurement - Right ventricular dysfunction severity | Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour | De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Severity reported as mild, moderate or severe) |
Countries
United States
Outcome results
None listed