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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG081582-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Primary objective:
To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective.
The specific aims of this epidemiologic investigation include:
The study will also explore the following:
This is a multicenter, prospective cohort study aimed at facilitating identification of individuals with ATTR-CA. Investigators will identify subjects with previous LSS surgery who have evidence of TTR amyloid deposits in spinal specimens. Subjects with localized TTR in 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).
Subjects will undergo nuclear scintigraphy, TTR genetic test, a clinical evaluation, electrocardiogram, and echocardiogram. Quality of life questionnaires will also be administered. Subjects 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.
This study is to be conducted at five study sites: Boston Medical Center, Cedars Sinai Medical Center, Cleveland Clinic, Columbia University Irving Medical Center, and Tufts University Medical Center. The Mayo Clinic will serve a Pathology research core to analyze spine specimens.
Most of the subjects are expected to complete all the study procedures and questionnaires on a single day.
Up to 1663 patients will be consented in this study to have spinal specimens examined for the presence of amyloid by Congo Red at the Mayo Clinic core lab. From the pool of subjects with amyloid detected (which anticipate will be 33% or at least 544), the investigators expect to recruit 163 participants to undergo cardiac phenotyping (Tc99m and cardiac evaluation). Among the 163 participants who undergo cardiac phenotyping, 98 will have TTR as the precursor protein identified by mass spectrometry and 65 will have an indeterminant precursor protein by mass spectrometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTR Negative | Participants who have undergone previous lumbar spinal, and/or carpel tunnel surgery will provide medical record data and spinal specimen for analysis of presence of ATTR amyloid. | ||
| ATTR Positive | Participants who have undergone previous lumbar spinal, and/or carpel tunnel surgery will provide medical record data, spinal specimen, prospective data from cardiac workup with confirmed ATTR amyloid in spinal specimen then undergo cardiac workup for cardiac phenotyping/genotyping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tc99-PYP or Tc99-HDMP Scan | Diagnostic Test | Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in their spine by myocardial uptake of Tc99-PYP. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimen and could be at risk for ATTR cardiac amyloidosis | To identify who can be at risk for ATTR Cardiac Amyloidosis. The investigator is going to collect spinal ligamentum flavum specimens and stain with congo red and those who result positive for ATTR amyloid in their spinal specimen will be counted | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects with ATTR-CA among those with localized TTR in their spinal tissue | To evaluate number of subjects with ATTR-CA among those with localized TTR in their spinal tissue. The investigator is going to perform standard of care (SOC) cardiac amyloidosis work up including PYP scan to confirm cardiac phenotype | up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following excludes eligibility for enrollment in this study:
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Previously procured surgical specimens from spinal surgery performed within 20 years prior to enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathew S Maurer, MD | Contact | 212-932-4537 | msm10@cumc.columbia.edu | |
| Samantha L Guadalupe, MHA | Contact | 212-932-4537 | slg2172@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mathew S Maurer, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Beverly Hills | California | 90211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29124734 | Background | Upadhya B, Pisani B, Kitzman DW. Evolution of a Geriatric Syndrome: Pathophysiology and Treatment of Heart Failure with Preserved Ejection Fraction. J Am Geriatr Soc. 2017 Nov;65(11):2431-2440. doi: 10.1111/jgs.15141. | |
| 31171094 | Background | Ruberg FL, Grogan M, Hanna M, Kelly JW, Maurer MS. Transthyretin Amyloid Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 Jun 11;73(22):2872-2891. doi: 10.1016/j.jacc.2019.04.003. |
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Blood will be drawn and analyzed for standard chemistry (Chem-7), liver function tests, NT-proBNP, troponin I and T, and TTR gene sequencing (see below). For subjects with ATTR-CA by positive uptake of 99mTc-PYP, further testing of prealbumin and monoclonal proteins (serum free light chains and immunofixation in serum and urine) will be performed. Additional aliquots will be stored at -80° for future analysis.
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
|
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02359 | United States |
|
| Mayo Clinic | Active, not recruiting | Rochester | Minnesota | 55905 | United States |
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D028227 | Amyloid Neuropathies, Familial |
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
Not provided
Not provided