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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04038879
Enrollment
300
Registered
2019-07-31
Start date
2010-07-31
Completion date
2023-07-31
Last updated
2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Regurgitation, Mitral Regurgitation

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.

Interventions

DIAGNOSTIC_TESTMRI

MRI of the heart

Sponsors

Atlantic Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation of echocardiography and MRI6 monthCorrelation of echocardiography and MRI
Change in LV EDV post surgery6 monthChange in LV EDV post surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026