A Study Of Myocardial Stiffness In Amyloidosis With Magnetic Resonance Elastography

NCT07216469 | Recruiting

• 1 other identifier: 25-006581
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective case control study to determine the feasibility and utility of myocardial stiffness assessment by cardiac magnetic resonance elastography (MRE) in patients with cardiac amyloidosis.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects able to complete a Magnetic Resonance Elastography exam

  Magnetic Resonance Elastography exam completion will be determined by signal to noise (SNR) ratio

  Baseline

• Mean Myocardial Stiffness

  Mean Myocardial stiffness will be measured by magnetic resonance elastography during early systole, end systole, early diastole and end diastole (kPa).

  Baseline

Study Arms (1)

Cardiac Amyloidosis

Diagnostic Test: Magnetic Resonance Elastography (MRE)

Interventions

Magnetic Resonance Elastography (MRE) DIAGNOSTIC_TEST

Patients will undergo a cardiac MRI with the addition of continuous free-breathing and breath-held MRE sequences.

Cardiac Amyloidosis

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Mayo Clinic's Cardiology, Hematology, and Cardiovascular Imaging clinics."

You may qualify if:

• Subjects are eligible to be included in the study if all the following criteria apply:
• Adult, age 20 and greater
• Subject is clinically stable without cardiovascular-related hospitalizations within 2 weeks prior to enrollment as assessed by the investigators
• Subject is able to provide written informed consent and is willing and able to complete study procedures
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Amyloidosis

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ian Chang, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Brown

CONTACT

507-538-8274; brown.kathy@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 14, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)