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

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03935178
Collaborator
(none)
14
1
29.9
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Measuring Right Ventricular Size and Function

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.

Study Design

Study Type:
Observational
Actual Enrollment :
14 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Actual Study Start Date :
Aug 5, 2019
Actual Primary Completion Date :
Jan 30, 2022
Actual Study Completion Date :
Jan 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Echocardiographic measurement - Right ventricular size [Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour]

    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.

  2. Echocardiographic measurement - Right ventricular function [Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour]

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

  3. Echocardiographic measurement - Right ventricular dysfunction severity [Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Scott Friedman, MD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eric S. Rothstein, Staff Physician, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT03935178
Other Study ID Numbers:
  • D19082 HVC 2019
First Posted:
May 2, 2019
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022