Status:
WITHDRAWN
Understanding the Metabolic and Functional Derangement of Primary Mitral Regurgitation: a Feasibility Study Using Carbon 11(C-11) Acetate Cardiac Positron Emission Tomography Magnetic Resonance Imaging (PET-MRI)
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The aim of this pilot imaging study is to investigate the underlying changes in myocardial oxidative metabolism, myocardial inflammation and alterations in extracellular volume in patients with chroni...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Patients with chronic, asymptomatic, compensated PMR evaluated in the UAB Structural Valve Clinic OR Normal controls identified from a normal aged matched population.
- Negative urine or serum β-human chorionic gonadotropin (hcg) test within 48 hours of \[11C\] acetate administration in women of childbearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.
Exclusion
- Inability to provide informed consent
- Pregnancy
- Inability to lie still for the imaging study
- Weight exceeding the weight limit of the PET imaging table (500 pounds)
- Comorbidities including any of the following: history of coronary artery disease, prior coronary revascularization, prior myocardial infarction, prior open sternotomy, history of congestive heart failure, history of non-ischemic cardiomyopathy including dilated, restrictive, hypertrophic, amyloid heart disease, cardiac sarcoidosis, history of hypertension, diabetes mellitus, chronic kidney disease with a glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 , history of other valvular heart disease defined as mitral stenosis, aortic stenosis, more than mild aortic regurgitation, more than mild tricuspid regurgitation, history of more than mild pulmonary hypertension and history of cancer with exposure to chemotherapy or radiotherapy.
- Contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
Key Trial Info
Start Date :
June 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04795856
Start Date
June 1 2027
End Date
August 1 2028
Last Update
January 24 2025
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