Status:
UNKNOWN
Primary Mitral Regurgitation Repair
Lead Sponsor:
Eric Y. Yang, MD PhD
Conditions:
Mitral Valve Insufficiency
Mitral Valve Prolapse
Eligibility:
All Genders
18+ years
Brief Summary
This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary ...
Detailed Description
The transition from compensated to decompensated chronic primary mitral regurgitation remains poorly understood in the clinical setting. Changes at the myocardial tissue level, such as scar formation ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Isolated mitral regurgitation
- of any primary mechanism and
- of moderate-to-severe (Sellers 3+) or greater severity, assessed by any imaging modality (echocardiography, angiography, cardiac MRI)
- Able to receive gadolinium-based contrast agent (estimated glomerular filtration rate \>30 mL/min/1.73 m2, no prior allergy to gadolinium contrast agents)
Exclusion
- Refusal to consent
- Pregnancy during the study
- Hemodynamically or clinically unstable
- Inability to undergo a CMR scan, which can include the following reasons: severe claustrophobia, ferromagnetic implants, implanted defibrillator, pacemaker, or abandoned pacemaker leads, cochlear implants, unable to lie flat
- Other diseases known to influence myocardial fibrosis development (coronary artery disease, diabetes mellitus, uncontrolled hypertension, infiltrative cardiomyopathy, myocarditis, hypertrophic cardiomyopathy, any cardiac tumors, moderate or more valvular heart disease other than primary mitral valve regurgitation)
Key Trial Info
Start Date :
May 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04067635
Start Date
May 25 2018
End Date
June 1 2021
Last Update
August 28 2019
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030