NCT04038879

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

13 years

First QC Date

July 28, 2019

Last Update Submit

August 2, 2019

Conditions

Mitral RegurgitationAortic Regurgitation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

MRIDIAGNOSTIC_TEST

MRI of the heart

Mitral/Aortic Regurgitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with mitral or aortic regurgitation

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Related Publications (7)

  • 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.

    PMID: 31005539BACKGROUND

  • 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.

    PMID: 29921479BACKGROUND

  • 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.

    PMID: 25790878BACKGROUND

  • Uretsky S, Gillam LD, Biederman RWW, Han Y, Jacob R, Martin ET, Langer M, Choi AD, Sultan I, Cavalcante JL, Shah DJ, Tong MS, Wolff SD, Sakul S, Guglielmo M, Pontone G. Sex differences in pre- and post-surgical left ventricular remodelling and outcomes in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1429-1437. doi: 10.1093/ehjci/jeaf151.

    PMID: 40392571DERIVED

  • 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.

    PMID: 35324429DERIVED

  • 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.

    PMID: 34915984DERIVED

  • 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.

    PMID: 32408828DERIVED

MeSH Terms

Conditions

Mitral Valve InsufficiencyAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesAortic Valve Disease

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Cardiovascular Imaging

Study Record Dates

First Submitted

July 28, 2019

First Posted

July 31, 2019

Study Start

July 1, 2010

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)