Atrioventricular Valve Regurgitation Vena Contracta; Echo Versus MRI

NCT01504880 | Completed

• 2 other identifiers: CHW 09/155GC 960
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tricuspid Valve Regurgitation, Non-rheumatic; Mitral Valve Regurgitation

Keywords

Mitral Regurgitation; Tricuspid Regurgitation; Vena Contracta

Outcome Measures

Primary Outcomes (1)

• Vena Contracta Value

  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 Outcomes (1)

• Mitral and Tricuspid Regurgitation Fraction

  At time of Echo and MRI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Benjamin Goot, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics, Cardiology

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 6, 2012
• Study Start: June 1, 2010
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)