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

NCT ID: NCT04038879

Last Updated: 2019-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mitral Regurgitation Aortic Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI

Intervention Type DIAGNOSTIC_TEST

MRI of the heart

Interventions

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MRI

MRI of the heart

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

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Seth Uretsky

Medical Director, Cardiovascular Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Morristown Medical Center

Morristown, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Seth Uretsky, MD

Role: primary

973-971-5597

Susan Miller, RN

Role: backup

9739715597

References

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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.

Reference Type BACKGROUND
PMID: 31005539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29921479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25790878 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40392571 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35324429 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34915984 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32408828 (View on PubMed)

Other Identifiers

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555087

Identifier Type: -

Identifier Source: org_study_id

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