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

• Conditions: Mitral Regurgitation; Aortic Regurgitation
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT04038879
• Lead Sponsor: Atlantic Health System

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2019-07-28
• Study First Submitted QC: 2019-07-28
• Study First Posted: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-06
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mitral/Aortic Regurgitation	MRI	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.

Primary Outcome Measures

Name	Time	Method
Correlation of echocardiography and MRI	6 month	Correlation of echocardiography and MRI
Change in LV EDV post surgery	6 month	Change in LV EDV post surgery

Trial Locations

Locations (1)

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States