PET-MRI Heart Scan for Mitral Valve Regurgitation

Overseen By Sebastian Eady

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Disqualifiers: Coronary artery disease, Hypertension, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pradeep Bhambhvani, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This study is for adults with chronic, asymptomatic primary mitral regurgitation (PMR) or healthy controls without heart conditions. Participants must be able to lie still for imaging and not exceed the PET table weight limit. Pregnant individuals, those unable to consent, with metal implants unsuitable for MRI, or significant comorbidities like heart failure or severe kidney disease cannot join.

Inclusion Criteria

I am not pregnant or have been menopausal for over a year or am surgically sterile.

Patients with a specific heart condition or healthy individuals from the same age group will not be included.

Exclusion Criteria

I cannot stay still for imaging tests.

You weigh more than 500 pounds, which is the maximum weight limit for the PET imaging table.

I cannot use a specific dye (ProHance) for MRI scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Study

Participants undergo PET-MRI to investigate myocardial oxidative metabolism, inflammation, and extracellular volume changes

0-48 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• [11C] acetate

Trial Overview [11C] acetate PET tracer is being tested to measure myocardial oxygen consumption in patients with PMR. Alongside this, cardiac MRI using a gadolinium-based contrast will assess myocardial inflammation and extracellular volume changes. The trial aims to enroll 12 participants for these non-invasive imaging studies.

Participant Groups

Group I: chronic compensated moderate-severe primary mitral regurgitation (PMR) Active Control 1 Intervention

Group II: Healthy Volunteers Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+