Measuring heart stiffness in amyloidosis with cardiac MRI elastography

Myocardial Stiffness in Amyloidosis by Magnetic Resonance Elastography - AMREloid Study

This tests whether cardiac MRI elastography can measure heart stiffness in adults with cardiac amyloidosis compared with people without the condition.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Mayo Clinic (other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT07216469 on ClinicalTrials.gov

What this trial studies

This is a prospective case-control project that uses cardiac magnetic resonance elastography (MRE) to measure myocardial stiffness in clinically stable adults with cardiac amyloidosis and in control participants. Participants with either transthyretin (ATTR) or light-chain (AL) cardiac amyloidosis will undergo cardiac MRE at Mayo Clinic Rochester and findings will be compared to matched controls. The goal is to determine feasibility and whether MRE-derived stiffness metrics differ between affected patients and controls. Imaging data will be collected and analyzed to explore links between stiffness measurements and existing clinical or imaging markers of cardiac amyloid involvement.

Who should consider this trial

Good fit: Adults aged 20 and older who are clinically stable, can undergo MRI, can give informed consent, and have confirmed ATTR or AL cardiac amyloidosis are ideal candidates.

Not a fit: People who are acutely ill or recently hospitalized, have MRI contraindications (for example certain implanted devices or severe claustrophobia), or who do not have cardiac involvement from amyloidosis may not benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could offer a noninvasive way to detect and monitor cardiac involvement in amyloidosis.

How similar studies have performed: Early pilot studies and small series of cardiac MRE have shown it can measure myocardial stiffness, but its specific application to cardiac amyloidosis remains relatively novel.

Eligibility criteria

Inclusion Criteria

Subjects are eligible to be included in the study if all the following criteria apply:

1. Adult, age 20 and greater
2. Subject is clinically stable without cardiovascular-related hospitalizations within 2 weeks prior to enrollment as assessed by the investigators
3. Subject is able to provide written informed consent and is willing and able to complete study procedures
4. Subject must meet criteria for either ATTR cardiac amyloidosis or AL cardiac amyloidosis from review of medical records as specified below:

   a. ATTR cardiac amyloidosis based on meeting all the following criteria:

   i. Diagnosis of amyloidosis within ten years prior to study screening

   ii. Transthyretin amyloid deposits in cardiac tissue OR Technetium (99mTc) bone scintigraphy with grade 2 or 3 cardiac uptake OR Transthyretin amyloid deposits in non-cardiac tissue with echocardiographic evidence of cardiac involvement or an end-diastolic mean wall thickness \> 12 mm OR Transthyretin amyloid deposits in non-cardiac tissue with cardiac MRI diagnostic of amyloidosis OR Clinical diagnosis of cardiac amyloidosis by the clinical provider

   b. AL cardiac amyloidosis based on meeting all the following criteria:

   i. Diagnosis of amyloidosis within ten years prior to study screening

   ii. Histopathologic diagnosis of amyloidosis with AL protein identification

   iii. Cardiac involvement as defined by: Amyloid deposits in cardiac deposits OR Echocardiography with an end-diastolic mean wall thickness \> 12 mm in the absence of other causes OR Elevated NT-proBNP (\>332 ng/L) in the absence of renal failure or atrial fibrillation OR Cardiac MRI diagnostic of amyloidosis OR Clinical diagnosis of cardiac amyloidosis by the clinical provider

   Exclusion Criteria

   Patients are ineligible to be included in the study if any of the following criteria apply:

1\. Unable to consent or unable to complete all study procedures 2. Unable to ambulate for 6 minutes (confirmed at study coordinator visit) 3. Unable to maintain in supine position for 30 minutes 4. Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator visit) 5. Contraindications for safe MRI scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator) 6. Presence of implantable cardiac pacemaker or defibrillator 7. History of complex congenital heart disease, prosthetic valves, prosthesis in the main pulmonary artery or ascending thoracic aorta 8. Significant artifact from prior MRI studies 9. Pregnant or breast-feeding women 10. Weight equal to or greater than 155 kg 11. In the judgment of the investigator, has clinically relevant ongoing medical condition or laboratory abnormalities or other condition that might jeopardize the participants safety, increase the participants risk from participation, interfere with the study, or confirmed study results

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Ian Chang, M.D. — Mayo Clinic
• Study coordinator: Kathy Brown

Conditions: Amyloidosis