PET-MRI Heart Scan for Mitral Valve Regurgitation

Phase < 1

Waitlist Available

Led By Pradeep Bhambhvani, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Be older than 18 years old

Must not have

Inability to lie still for the imaging study

Contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-48 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at changes in the heart of people with a particular heart condition, and comparing them to healthy controls. They will use PET and MRI scans to look at different aspects of the heart, and how well it is functioning.

Who is the study for?

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.

What is being tested?

[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.

What are the potential side effects?

Potential side effects may include reactions related to the [11C] acetate PET tracer and gadolinium-based contrast agent used during MRI scans such as nausea, headache, dizziness, or allergic reactions. However, serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot stay still for imaging tests.

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

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I have a history of heart disease, high blood pressure, diabetes, kidney issues with low GFR, or severe valve problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.