Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities

Dartmouth-Hitchcock Medical Center14 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Hypertension Valvular Heart Disease Congenital Heart Disease Congestive Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Echocardiographic measurement - Right ventricular size

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.

Time frame: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour

Echocardiographic measurement - Right ventricular function

De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies.

Time frame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour

Echocardiographic measurement - Right ventricular dysfunction severity

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)