Molecular Imaging of Primary Amyloid Cardiomyopathy
Brigham and Women's Hospital
171 participants
Apr 1, 2016
INTERVENTIONAL
Conditions
Summary
Cardiac amyloidosis is a major cause of early treatment-related death and poor overall survival in individuals with systemic light chain amyloidosis. This project will develop a novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to guide the development of novel life-saving treatments.
Eligibility
Inclusion Criteria5
- Age > 18 years
- Diagnosis of light chain amyloidosis by standard criteria (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/ bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed)
- For subjects traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official confirmation of biopsy results. If biopsy is negative for AL amyloidosis, subject will be considered a screen failure. There will be no more than 10 subjects who fall under this screen failure for the duration of the study.
- Subjects with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D.
- Willing and able to provide consent
Exclusion Criteria10
- Hemodynamic instability
- Decompensated heart failure (unable to lie flat for 1 hour)
- Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
- Known obstructive epicardial coronary artery disease with stenosis > 50% in any single territory
- Severe claustrophobia despite use of sedatives
- Presence of MRI contraindications such as metallic implants (pacemaker or ICD) at the time of study enrollment except for Control Heart Failure subjects. Control HF subjects with no devices, or, with strictly MR compatible devices will be eligible to undergo MRI.
- Significant renal dysfunction with estimated glomerular filtration rate < 30 ml/min/m2 within 14 days of each cardiac MRI study. Subjects who develop renal dysfunction over the course of the study, meeting criteria listed above, will be excluded from the cardiac MRI scan except for control HF subjects. These subjects with eGFR < 30 ml/min/1.73 m2 will undergo MRI without gadolinium contrast.
- Subjects on dialysis will be excluded
- Pregnant state. For women in child bearing age, a urine pregnancy test will be performed prior to the PET and the cardiac MRI studies
- Documented allergy to F-18 florbetapir, C-11 acetate or gadolinium.
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Interventions
F-18 florbetapir PET scan, C-11 acetate PET scan
Cardiac MRI with gadolinium contrast.
N-13 ammonia PET scan following supine bicycle stress.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02641145