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

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Dartmouth Health

Status

Terminated

Conditions

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

Treatments

Diagnostic Test: Measuring Right Ventricular Size and Function

Study type

Observational

Funder types

Other

Identifiers

NCT03935178
D19082 HVC 2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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