Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
NCT Number: NCT07216469
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.
Interested in participating?
Request Info20 year and older
All sexes
Observational
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects are eligible to be included in the study if all the following criteria apply:
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:
Patients will undergo a cardiac MRI with the addition of continuous free-breathing and breath-held MRE sequences.
Time frame: Baseline
Magnetic Resonance Elastography exam completion will be determined by signal to noise (SNR) ratio
Time frame: Baseline
Mean Myocardial stiffness will be measured by magnetic resonance elastography during early systole, end systole, early diastole and end diastole (kPa).
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Myocardial Stiffness in Amyloidosis by Magnetic Resonance Elastography - AMREloid Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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