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The purpose of this study is to determine the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among patients with moderate and severe aortic stenosis in Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).
Residents of Southeast Minnesota over 75 years of age with an inpatient or outpatient diagnosis of moderate or severe aortic stenosis will be consecutively identified using an automated bi-weekly review of the echo lab calendar (on Mondays and Fridays) at Mayo Clinic Rochester (MCR) and Mayo Clinic Health System (MCHS) sites. Participants will be consented to undergo venipuncture, urine collection and 99mTc-PYP SPECT/CT imaging to rule in/out the diagnosis of TTR-CA. Hence, the prevalence of TTR-CA will be defined. To place this prevalence in perspective of the global aortic stenosis cohort in the community, a rigorous screening log will be maintained to allow generation of a comprehensive CONSORT diagram. Importantly, baseline characteristics of patients who qualify for our study but decline to consent will still be collected provided that consent for use of their records for medical research had previously been granted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPECT/CT | Other | 99mTc-PYP single-photon positive emission computed tomography with computed tomography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-PYP | Drug | Radioisotope used by SPECT/CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of TTR-CA in patients with moderate and severe aortic stenosis | Determine the prevalence of Transthyretin Cardiac Amyloidosis in a community based cohort of consecutive patients with moderate or severe aortic stenosis using 99mTc-Pyrophosphate (99mTc-PYP) single-photon positive emission computed tomography with computed tomography (SPECT/CT) | Baseline |
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Inclusion Criteria:
Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County)
Age ≥ 75 years
Current diagnosis of moderate or severe aortic stenosis by most recent (within 6 months at most) echocardiogram as defined by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar F Abou Ezzeddine, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| C567782 | Amyloidosis, Hereditary, Transthyretin-Related |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016698 | Technetium Tc 99m Pyrophosphate |
| ID | Term |
|---|---|
| D011756 | Diphosphates |
| D011122 | Polyphosphates |
| D010710 | Phosphates |
| D010756 | Phosphoric Acids |
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| D014694 |
| Ventricular Outflow Obstruction |
| D017976 |
| Phosphorus Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D017553 | Phosphorus Compounds |
| D017556 | Technetium Compounds |