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

NCT ID: NCT03935178

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2022-01-30

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eric S. Rothstein

Staff Physician, Heart and Vascular Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

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Other Identifiers

D19082 HVC 2019

Identifier Type: -

Identifier Source: org_study_id