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)

• ClinicalTrials.gov Identifier: NCT04795856
• Recruitment Status: Not yet recruiting
• First Posted: March 12, 2021
• Last Update Posted: February 8, 2023
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Pradeep Bhambhvani, MD, University of Alabama at Birmingham

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Contacts

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

Locations

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

Investigators

• Principal Investigator: Pradeep Bhambhvani, MD; University of Alabama at Birmingham

More Information

• 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
• 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

Additional relevant MeSH terms:

Mitral Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases