Measuring heart stiffness in amyloidosis with cardiac MRI elastography

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ian Chang, M.D. — Mayo Clinic
• Study coordinator: Kathy Brown
• Email: brown.kathy@mayo.edu
• Phone: 507-538-8274

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• 18F‑FT8 PET imaging for light‑chain (AL) cardiac amyloidosis

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• Belantamab Mafodotin with a chemotherapy combo for newly diagnosed AL amyloidosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.