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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03935178

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted October 9, 2020

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:Acute Coronary Syndrome
    Congenital Heart Disease
    Congestive Heart Failure
    Pulmonary Embolism
    Pulmonary Hypertension
    Valvular Heart Disease
  • Intervention/Treatment: Diagnostic Test: Measuring Right Ventricular Size and Function
  • Phase: N/A
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
  • Estimated Enrollment: 50 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: August 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: August 2021
Outcome Measures
  • Primary Outcome Measures: 1. Echocardiographic measurement - Right ventricular size [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.
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

Contacts and Locations
Contacts

Contact: Allison J Hawke 603-650-7985 allison.j.hawke@hitchcock.org

Contact: Eric S Rothstein (603) 650-5724 Eric.S.Rothstein@hitchcock.org

Locations

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

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

More Information