Atrioventricular Valve Regurgitation Vena Contracta; Echo Versus MRI

February 4, 2020 updated by: Benjamin Goot, Medical College of Wisconsin

Evaluation of Mitral and Tricuspid Regurgitation: Cardiovascular Magnetic Resonance Imaging Versus Echocardiographic Doppler Color Flow Mapping of the Vena Contracta

The purpose of this pilot study is to evaluate mitral (left atrioventricular valve) and tricuspid (right atrioventricular valve (AVV)) regurgitation using cardiac magnetic resonance imaging (CMR) as the non-invasive "gold standard" compared to transthoracic echocardiography (TTE) to evaluate measurements of the width of the regurgitation jet (vena contracta (VC)) to demonstrate the utility of the VC as a means to objectively evaluate atrioventricular valve regurgitation. In addition, feasibility and other quantitative and qualitative measures of regurgitation will be compared between CMR and TTE.

  • Hypothesis 1: The ability to objectively evaluate atrioventricular valve regurgitation and VC width with TTE and CMR has a high feasibility rate with acceptable intra and inter-observer variability by two independent readers.
  • Hypothesis 2: There will be positive correlation between the TTE measurement of the VC width and quantitative assessment of atrioventricular valve regurgitation by TTE and CMR.
  • Hypothesis 3: There will be a positive correlation between the quantitative measurements of atrioventricular valve regurgitation by phase contrast velocity encoded CMR with quantitative values as measured by TTE.
  • Hypothesis 4: There will be a positive correlation between qualitative assessment of atrioventricular valve regurgitation by CMR compared to TTE.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND, SIGNIFICANCE, AND RATIONALE (including preliminary studies and any results) The integrity of the two atrioventricular valves (AVV)(i.e., the mitral and tricuspid valve) plays an important role in the evaluation and management of patients with congenital and acquired heart disease. Loss of valve integrity (i.e., valve leakage in the reverse direction of normal blood flow), is known as valve regurgitation. Increasing severity of mitral regurgitation has been associated with increased mortality and morbidity. Tricuspid regurgitation can be a progressive problem that results in right atrial and ventricular dilation and possible right heart failure. Similarly, mitral valve regurgitation can result in left atrial and left ventricular enlargement. Treatment options for valvular regurgitation are based upon the degree of regurgitation in both adults and children. Therefore, assessment of the degree of AV valvular regurgitation has important clinical ramifications. AV valve regurgitation can be assessed in several ways, including both invasive and noninvasive modalities. The invasive assessment is performed by cardiac catheterization which enables qualitative and quantitative measurements of AV valve regurgitation and in the past has been considered the "gold standard". Noninvasive assessment is still the preferred method and consists of echocardiography, electrocardiography, chest x-ray, and CMR. TTE can be used qualitatively to describe the amount of AV valve regurgitation by the degree of color flow Doppler reflux into the left atrium during left ventricular contraction. This approach grades the regurgitation as mild, moderate or severe similar to angiographic grading systems, but is relatively subjective and affected by technical factors. TTE can quantitatively evaluate AV valve regurgitation through calculation of regurgitation orifice area, regurgitation volume and regurgitation fraction. These methods have been shown to have a good correlation when used for mitral valves compared to cardiac catheterization and CMR in adults. However, quantitative techniques are time consuming and require multiple measurements and more complex calculations. A simpler technique of objectively characterizing the regurgitation of the AV valves by TTE is measuring the width of the vena contracta (VC). The VC is the narrowest portion of a regurgitant jet which occurs at the level of or just below the valve leaflets and represents the effective regurgitant orifice. In adult studies, this method has shown that increase in VC width of the mitral valve strongly correlates with qualitative angiographic grades and quantitative measurements of regurgitant volume by cardiac catheterization and is a better assessment of regurgitation than measuring the regurgitant jet by TTE. Changes in VC width also had strong correlation with quantitative measurements of regurgitant volume and regurgitant orifice area using TTE. It is our intent to evaluate the feasibility and correlation of measurements of AV valve regurgitation by TTE with focus on the VC in pediatric patients compared to the non-invasive "gold standard" measurements by CMR.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for clinically indicated MRI and have had an echocardiogram in the last 6 months with AV Valve (AVV) Insufficiency.

Description

Inclusion Criteria:

  • Audible AV valve regurgitation on clinical exam, as noted by most recent clinic note.
  • Clinically indicated CMR study scheduled and have had an echocardiogram in the last 6 months

Exclusion Criteria:

  • Poor quality CMR study
  • Unable to complete a CMR
  • Have a contraindication to CMR scan (e.g., pregnancy, pacemaker or defibrillator presence, unable to hold still within scanner for imaging)
  • Common AV valve
  • Corresponding semilunar valve regurgitation which precludes use of stroke volume comparison as a second means of assessing AVV regurgitation by CMR
  • Intracardiac shunts which precludes use of stroke volume comparison as a second means of assessing AVV regurgitation by CMR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vena Contracta Value
Time Frame: At time of Echo and MRI
Comparison of the echocardiographic measured vena contracta with quantitative value of mitral or tricuspid regurgitation as measured by MRI.
At time of Echo and MRI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitral and Tricuspid Regurgitation Fraction
Time Frame: At time of Echo and MRI
Quantitative echo measurements of mitral or tricuspid valve regurgitation fraction will be correlated to MRI derived regurgitation fraction of the mitral or tricuspid valves.
At time of Echo and MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

Children's Hospital and Health System Foundation, Wisconsin

Investigators

  • Principal Investigator: Benjamin Goot, MD, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 19, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHW 09/155
  • GC 960 (Other Identifier: Medical College of Wisconsin)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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