Recruiting

Echocardiography vs. Cardiovascular Magnetic Resonance Imaging

Sponsor:

Atlantic Health System

Code:

NCT04038879

Conditions

Mitral Regurgitation

Aortic Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MRI

Study Details

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.

Conditions

Mitral Regurgitation

Aortic Regurgitation

Study ID

NCT04038879

Start date

Jul, 2010

Status verified date

Aug, 2019

Completion date

Jul, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Mitral/Aortic Regurgitation

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.

Interventions

MRI

MRI of the heart

Primary outcome measure

  • Correlation of echocardiography and MRI [ Time Frame: 6 month ]
  • Change in LV EDV post surgery [ Time Frame: 6 month ]

Central Contacts and Locations

Locations

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Principal Investigator:

Seth Uretsky, MD

More Information

Sponsor

Atlantic Health System

Last update posted

Aug 6, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2019-08-06.