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Clinical Trials/NCT04038879
NCT04038879
Unknown
N/A

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 enrollmentJuly 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
Atlantic Health System
Enrollment
300
Locations
1
Primary Endpoint
Correlation of echocardiography and MRI
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 2023
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seth Uretsky

Medical Director, Cardiovascular Imaging

Atlantic Health System

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.

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

Study Sites (1)

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