Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging
Study Overview
Brief Summary
The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).
Detailed Description
40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Moderate or more tricuspid regurgitation
Exclusion Criteria
- •Prior tricuspid valve prosthesis
- •Pacemaker/defibrillator that would impede MRI imaging
- •Planned tricuspid valve surgery
- •Primary liver pathology
Outcomes
Primary Outcomes
Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging
Time Frame: 1 year
Incidence of severity of TR by CMR as compared with current gold standard (TTE)
Secondary Outcomes
- Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography(1 year)
Investigators
Mohamad Adnan Alkhouli
Professor of Medicine
Mayo Clinic