Clinical trial NCT04038879: Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation
Official title: Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Regurgitation
Aortic Regurgitation
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with mitral or aortic regurgitation

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation of echocardiography and MRI
timeFrame: 6 month
measure: Change in LV EDV post surgery
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.