Clinical trial NCT03935178: Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Hypertension
Valvular Heart Disease
Congenital Heart Disease
Congestive Heart Failure
Pulmonary Embolism
Acute Coronary Syndrome
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is for people who are18-years or older that are undergoing cardiac magnetic resonance imaging (CMR) as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH.

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.

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

Primary outcomes:
measure: Echocardiographic measurement - Right ventricular size
timeFrame: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour
measure: Echocardiographic measurement - Right ventricular function
timeFrame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
measure: Echocardiographic measurement - Right ventricular dysfunction severity
timeFrame: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Scott Friedman, MD
role: PRINCIPAL_INVESTIGATOR
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