NCT03935178

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

A Single-Center, Blinded, Randomized Control Trial Evaluating Different Approaches to Evaluation of Right Ventricular Size and Function Using the Upper Valley Right Ventricle Algorithm and Novel Imaging Modalities

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Hypertension
• Valvular Heart Disease
• Congenital Heart Disease
• Congestive Heart Failure
• Pulmonary Embolism
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Measuring 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

Timeline

• Start date: 2019-08-05
• Primary completion: 2022-01-30
• Completion: 2022-01-30
• First posted: 2019-05-02
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States