Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation

The primary treatment for patients determined to have severe aortic or mitral regurgitation is surgical repair or replacement their valves. The most commonly used tool to quantify the severity mitral and aortic regurgitation is echocardiography. Studies have shown that echocardiography may have significant limitations in quantifying regurgitant volume. MRI has recently been shown to easily and reproducibly quantify regurgitation. To better understand how to accurately quantify severity of regurgitation the investigators propose this study with the following aims: 1) compare MRI to echocardiography in the evaluation of regurgitant volume in patients with aortic or mitral regurgitation and 2) to assess which technique is better at predicting the response of the left ventricle to valve surgery.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation; Aortic Regurgitation
• Intervention / Treatment: Diagnostic test: MRI

Detailed Description

The primary treatment for patients determined to have severe aortic or mitral regurgitation is surgical repair or replacement their valves. The most commonly used tool to quantify the severity mitral and aortic regurgitation is echocardiography. Studies have shown that echocardiography may have significant limitations in quantifying regurgitant volume. MRI has recently been shown to easily and reproducibly quantify regurgitation. To better understand how to accurately quantify severity of regurgitation the investigators propose this study with the following aims: 1) compare MRI to echocardiography in the evaluation of regurgitant volume in patients with aortic or mitral regurgitation and 2) to assess which technique is better at predicting the response of the left ventricle to valve surgery.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Morristown Medical Center
      • Contact: Seth Uretsky, MD; Phone Number: 973-971-5597; Email: seth.uretsky@atlantichealth.org
      • Contact: Susan Miller, RN; Phone Number: 9739715597; Email: susan.miller@atlantichealth.org
      • Principal Investigator: Seth Uretsky, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with mitral or aortic regurgitation

Description

Inclusion Criteria:

• Age ≥18 years of age
• Able to give informed consent
• Referred for isolated aortic or mitral valve repair or replacement due to valve regurgitation

Exclusion Criteria:

• Inability to provide consent.
• Pregnancy
• Claustrophobia
• Metallic contraindications to MRI (e.g. noncompatible aneurysm clip etc)
• Known intracardiac shunt
• Planned concomitant cardiac surgical procedure such as coronary artery bypass, septal myomectomy, or other valve procedure.
• More than mild mitral or aortic stenosis.
• For patients enrolled with mitral regurgitation: greater than mild aortic regurgitation.
• For patients enrolled with aortic regurgitation: greater than mild mitral regurgitation.
• Hypertrophic cardiomyopathy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mitral/Aortic Regurgitation; Subjects identified with mitral or aortic regurgitation will be asked to undergo testing with trans thoracic echocardiogram, stress echocardiography, and cardiac MRI with and without contrast. In addition, patients will be asked to answer the KCC and EQ5DL questionnaires.	Diagnostic test: MRI; MRI of the heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of echocardiography and MRI	Correlation of echocardiography and MRI	6 month
Change in LV EDV post surgery	Change in LV EDV post surgery	6 month

Collaborators and Investigators

• Sponsor: Atlantic Health System

Publications and helpful links

General Publications

• Uretsky S, Aldaia L, Marcoff L, Koulogiannis K, Hiramatsu S, Argulian E, Rosenthal M, Gillam LD, Wolff SD. The Effect of Systolic Variation of Mitral Regurgitation on Discordance Between Noninvasive Imaging Modalities. JACC Cardiovasc Imaging. 2019 Dec;12(12):2431-2442. doi: 10.1016/j.jcmg.2019.02.014. Epub 2019 Apr 17.
• Uretsky S, Argulian E, Supariwala A, Marcoff L, Koulogiannis K, Aldaia L, Chaudhry FA, Wolff SD, Gillam LD. A Comparative Assessment of Echocardiographic Parameters for Determining Primary Mitral Regurgitation Severity Using Magnetic Resonance Imaging as a Reference Standard. J Am Soc Echocardiogr. 2018 Sep;31(9):992-999. doi: 10.1016/j.echo.2018.04.006. Epub 2018 Jun 18.
• Uretsky S, Gillam L, Lang R, Chaudhry FA, Argulian E, Supariwala A, Gurram S, Jain K, Subero M, Jang JJ, Cohen R, Wolff SD. Discordance between echocardiography and MRI in the assessment of mitral regurgitation severity: a prospective multicenter trial. J Am Coll Cardiol. 2015 Mar 24;65(11):1078-88. doi: 10.1016/j.jacc.2014.12.047.
• Uretsky S, Animashaun IB, Sakul S, Aldaia L, Marcoff L, Koulogiannis K, Argulian E, Rosenthal M, Wolff SD, Gillam LD. American Society of Echocardiography Algorithm for Degenerative Mitral Regurgitation: Comparison With CMR. JACC Cardiovasc Imaging. 2022 May;15(5):747-760. doi: 10.1016/j.jcmg.2021.10.006. Epub 2022 Jan 12.
• Uretsky S, Morales DCV, Aldaia L, Mediratta A, Koulogiannis K, Marcoff L, Sakul S, Wolff SD, Gillam LD. Characterization of Primary Mitral Regurgitation With Flail Leaflet and/or Wall-Impinging Flow. J Am Coll Cardiol. 2021 Dec 21;78(25):2537-2546. doi: 10.1016/j.jacc.2021.09.1382.
• Uretsky S, Aldaia L, Marcoff L, Koulogiannis K, Argulian E, Lasam G, Gillam L. Concordance and Discordance of Echocardiographic Parameters Recommended for Assessing the Severity of Mitral Regurgitation. Circ Cardiovasc Imaging. 2020 May;13(5):e010278. doi: 10.1161/CIRCIMAGING.119.010278. Epub 2020 May 15.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: July 28, 2019
• First Submitted That Met QC Criteria: July 28, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Mitral Valve Insufficiency; Aortic Valve Insufficiency
• Other Study ID Numbers: 555087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No