Ultrasound Therapy In Cardiac Amyloidosis
Brigham and Women's Hospital
Summary
This is a prospective pilot clinical study of subjects with cardiac amyloidosis and control subjects without amyloidosis where we plan to evaluate changes in myocardial blood flow, systolic and diastolic function before and after sonotherapy.
Description
70 subjects will be enrolled in this study in 3 study groups: A) 30 subjects with light chain cardiac amyloidosis B) 30 subjects with transthyretin cardiac amyloidosis and C) 10 subjects without amyloidosis. All subjects will undergo rest 2D echocardiography, rest N-13 ammonia or rubidium-82 perfusion PET, Definity infusion with high mechanical index (MI) imaging defined as sonotherapy in this study protocol.
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age \> 18 years for AL-CA, \> 65 years for ATTR-CA, \> 65 years for controls * Willing and able to provide consent * Diagnosis of systemic light chain amyloidosis by standard criteria (see below) and in hematological remission (normal serum free light chain levels) * (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) AND * proof of cardiac involvement by AL amyloid…
Interventions
- Combination ProductSonotherapy
Use of high mechanical index ultrasound therapy with intravenous Definity contrast infusion
Location
- Brigham and Women's HospitalBoston, Massachusetts