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)
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|ClinicalTrials.gov Identifier: NCT04795856|
Recruitment Status : Not yet recruiting
First Posted : March 12, 2021
Last Update Posted : February 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Regurgitation||Drug: [11C] acetate||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The healthy group will establish a baseline for the moderate- severe mitral valve regurgitation (PMR) group.|
|Masking:||None (Open Label)|
|Official Title:||Understanding the Metabolic and Functional Derangement of Primary Mitral Regurgitation: a Feasibility Study Using C-11 Acetate Cardiac PET-MRI|
|Estimated Study Start Date :||June 18, 2025|
|Estimated Primary Completion Date :||August 31, 2028|
|Estimated Study Completion Date :||August 31, 2028|
|Active Comparator: chronic compensated moderate-severe primary mitral regurgitation (PMR)||
Drug: [11C] acetate
|Active Comparator: Healthy Volunteers||
Drug: [11C] acetate
- Quantitatively correlate metabolic findings from the PET component with quantitative T1 and T2 parametric mapping from the cardiac MR component of the hybrid PET-MR study. [ Time Frame: 0-48 hours ]Parametric analysis of T1 and T2 mapping will be performed using dedicated software (Qmap, Medis).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- Inability to provide informed consent
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795856
|Contact: Sebastian Eadyemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35249|
|Contact: Pradeep Birmingham, MD|
|Principal Investigator:||Pradeep Bhambhvani, MD||University of Alabama at Birmingham|
|Responsible Party:||Pradeep Bhambhvani, MD, Professor, Division of Molecular Imaging and Therapeutics, University of Alabama at Birmingham|
|Other Study ID Numbers:||
|First Posted:||March 12, 2021 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Mitral Valve Insufficiency
Heart Valve Diseases