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

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04038879
• Other study ID #: 555087
• Status: Recruiting
• Start date: July 2010
• Est. completion date: July 2023

Study information

• Verified date: August 2019
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Vomiting

Intervention

Diagnostic Test:
• MRI
MRI of the heart

Locations

Country	Name	City	State
United States	Morristown Medical Center	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 Apr 10. pii: S1936-878X(19)30248-7. doi: 10.1016/j.jcmg.2019.02.014. [Epub ahead of print] — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of echocardiography and MRI	Correlation of echocardiography and MRI	6 month
Primary	Change in LV EDV post surgery	Change in LV EDV post surgery	6 month