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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores changes in heart function in individuals with mitral valve regurgitation, a condition where the heart valve fails to close tightly, allowing blood to flow backward. Researchers use a special scan to assess how well the heart uses oxygen and to detect any signs of inflammation or volume changes in heart tissue. The trial employs [11C] acetate, a tracer in PET-MRI scans, to evaluate heart metabolism. It seeks participants with chronic, moderate-severe mitral valve regurgitation who are asymptomatic, as well as healthy volunteers for comparison. Participants should have been evaluated at the UAB Structural Valve Clinic and must not have certain heart diseases, diabetes, or kidney issues. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a unique opportunity to contribute to groundbreaking heart health research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this PET-MRI heart scan is safe for patients with mitral valve regurgitation?

Research has shown that using [11C] acetate in PET scans is generally safe for heart studies. This imaging method effectively assesses heart function without causing major side effects. For example, it has been used to evaluate energy use in patients with heart issues, such as a leaky heart valve.

No serious side effects have been reported in these studies, suggesting that [11C] acetate PET scans are safe for individuals. However, since this trial is in an early stage, it primarily focuses on collecting initial safety information. This means the treatment hasn't undergone extensive safety testing yet, but early trials aim to identify any serious risks promptly. So far, [11C] acetate appears to be a safe tool for studying heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PET-MRI Heart Scan for Mitral Valve Regurgitation trial because it's exploring a cutting-edge imaging technique that could transform how we evaluate heart conditions. Unlike conventional methods like echocardiograms or standard MRIs, this trial combines the power of PET and MRI to provide highly detailed images of the heart. This approach uses [11C] acetate, which could offer more precise insights into heart metabolism and function. The potential to improve diagnosis and tailor treatments more effectively makes this exploration particularly promising.

What evidence suggests that this imaging method is effective for assessing mitral valve regurgitation?

Research shows that [11C] acetate aids in studying heart function by measuring the heart's energy use, which is vital for understanding heart health, even without symptoms. Studies have demonstrated that [11C] acetate can accurately assess this energy use. This information is crucial for understanding heart issues like mitral valve regurgitation, where the heart valve doesn't close properly. Although not a treatment, [11C] acetate offers valuable insights into heart health. The trial will include participants with chronic compensated moderate-severe primary mitral regurgitation and healthy volunteers, enabling a comprehensive analysis of heart function using [11C] acetate. ^{1 3 5 6 7}

Who Is on the Research Team?

Pradeep Bhambhvani, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36604185/

Myocardial External Efficiency in Asymptomatic Severe ... We used 11 C-acetate PET to noninvasively measure myocardial mechanical external efficiency (MEE), which is the energetic ratio of external cardiac work and ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/64/4/645

Myocardial External Efficiency in Asymptomatic Severe ... We used 11 C-acetate PET to noninvasively measure myocardial mechanical external efficiency (MEE), which is the energetic ratio of external cardiac work and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1071358123024807

Automatic calculation of myocardial external efficiency ... Therefore, the aim of this study was to evaluate the accuracy of MEE derived from a single dynamic 11C-acetate PET scan. In addition, obtained MEE values for ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/early/2023/01/05/jnumed.122.264945

Myocardial external efficiency in asymptomatic severe primary ... Myocardial external efficiency in asymptomatic severe primary mitral regurgitation using 11C-acetate positron emission tomography · Jens Sorensen.

5. researchgate.net researchgate.net/publication/326002990_Automatic_calculation_of_myocardial_external_efficiency_using_a_single_11C-acetate_PET_scan

Automatic calculation of myocardial external efficiency ... We developed a fully automated method for estimating MEE based on a single 11C-acetate PET scan without ECG-gating. Methods and results: Ten healthy controls, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04795856

Study Details | NCT04795856 | Understanding the ... The aim of this pilot imaging study is to investigate the underlying changes in myocardial oxidative metabolism, myocardial inflammation and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9724852/

the EXPAND study: Mitral valve leaflet adverse events ... Mitral valve repair with third-generation MitraClip NTR/XTR systems is safe for percutaneous treatment of mitral regurgitation. The rate of adverse events ...