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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
Information provided by (Responsible Party):
Pradeep Bhambhvani, MD, University of Alabama at Birmingham

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 chronic compensated moderate-severe primary mitral regurgitation (PMR). The PET tracer [11C] acetate will be used to image and quantify myocardial oxygen consumption (MVO2) in hearts of the study participants. Cardiac magnetic resonance imaging (CMR) using a gadolinium-based contrast agent (GBCA) will be performed to assess for and quantify expansion of myocardial extracellular volume (ECV) and myocardial inflammation. We will enroll a total of 12 participants, nine of whom will be patients with chronic, compensated asymptomatic moderate-severe PMR evaluated at the UAB Cardiovascular Disease and Structural Valve Clinic and three normal control subjects.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Drug: [11C] acetate Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
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)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Active Comparator: chronic compensated moderate-severe primary mitral regurgitation (PMR) Drug: [11C] acetate
PET Tracer

Active Comparator: Healthy Volunteers Drug: [11C] acetate
PET Tracer

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

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

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Contact: Sebastian Eady 205-996-2636 smeady@uabmc.edu

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Contact: Pradeep Birmingham, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Pradeep Bhambhvani, MD University of Alabama at Birmingham
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Responsible Party: Pradeep Bhambhvani, MD, Professor, Division of Molecular Imaging and Therapeutics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04795856    
Other Study ID Numbers: R20-178
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases