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Clinical Trials/NCT04038879
NCT04038879UnknownNot Applicable

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

Atlantic Health System1 site in 1 country300 target enrollmentStarted: July 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
Correlation of echocardiography and MRI

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Correlation of echocardiography and MRI

Time Frame: 6 month

Correlation of echocardiography and MRI

Change in LV EDV post surgery

Time Frame: 6 month

Change in LV EDV post surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seth Uretsky

Medical Director, Cardiovascular Imaging

Atlantic Health System

Study Sites (1)

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