This is a multicenter, prospective cohort study aimed at facilitating identification of individuals with ATTR-CA. We will identify subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimens. Those with localized TTR in their spinal tissue will be invited to an on-site visit and be evaluated for the presence of clinical manifestations of ATTR cardiac amyloidosis (ATTR-CA).
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Amyloidosis
All genders
60+
Recruiting now
Overview
Principal Investigator: Ayan Patel, MD
Contact Us
Easton Cummins/Gaurav Das
Study details
Inclusion Criteria
- 1. Clinically indicated lumbar spinal decompressive surgery that involved removal of the ligamentum flavum 5 to 15 years prior to enrollment.
- 2. Age >60 years at the time of the surgery.
- 3. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
Exclusion Criteria
- 1. Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA).
- 2. Known TTR amyloidosis.
- 3. Lumbar surgery for indications other than spinal stenosis.
Study Requirements
Patients will undergo nuclear scintigraphy, TTR genetic test, a clinical evaluation, electrocardiogram, and echocardiogram. Quality of life questionnaires will also be administered. Those who have myocardial retention of the imaging radiotracer with a Perugini score equal to 2 (uptake equal to bone) or 3 (uptake greater than bone) and confirmation by SPECT or SPECT/CT that the uptake is myocardial in nature and have no evidence of monoclonal proteins will be diagnosed with ATTR-CA. Most of the patients are expected to complete all the study procedures and questionnaires on a single day.