A Study Of Myocardial Stiffness In Amyloidosis With Magnetic Resonance Elastography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Resonance Elastography (MRE).
- Who it may be relevant to
- Registry conditions: Amyloidosis. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Myocardial Stiffness in Amyloidosis by Magnetic Resonance Elastography - AMREloid Study
Overview
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.
Interventions
- Diagnostic test Magnetic Resonance Elastography (MRE)
Patients will undergo a cardiac MRI with the addition of continuous free-breathing and breath-held MRE sequences.
Primary outcome measures
- Percentage of subjects able to complete a Magnetic Resonance Elastography exam [Time frame: Baseline]
- Mean Myocardial Stiffness [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07216469 · 25-006581