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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To estimate the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among Heart Failure with Preserved Ejection Fraction (HFpEF) patients with increased LV wall thickness in Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).
Residents of Southeast Minnesota over 60 years of age with an inpatient or outpatient diagnosis of heart failure (HF) will be consecutively identified in real-time using a natural language processing (NLP) search engine, their HF diagnosis validated, and those with a recent (≤ 12 months) echocardiogram documenting a preserved EF( ≥ 40%) and LV wall thickening 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 HFpEF 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-PYP | Drug | Radioisotope used in the SPECT/CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of TTR-CA | Determine the prevalence of Transthyretin Cardiac Amyloidosis in a community based cohort of consecutive Heart Failure with Preserved Ejection Fraction patients with increased Left Ventricular wall thickness 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)
Current diagnosis of HF per NLP search
Age > 60 years
Clinically obtained echocardiogram within 12 months of index visit showing:
Objective evidence of HF defined as one or more of the following present within 24 months of index visit:
Exclusion Criteria
Documentation of previous EF < 40%
Any cardiac surgery or major chest trauma within 4 weeks of index visit
Presence or history of hemodynamically significant left sided valvular disease defined as:
Myocardial infarction within 4 weeks of index visit defined by typical angina, EKG changes and significant change in serial troponins. Note that chronic troponin elevation is extremely common in cardiac amyloidosis. Hospitalized patients with troponin elevation but no significant change (delta) on serial testing will NOT be excluded.
Prior or current exposure to Plaquenil (Hydroxychloroquine)
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| Name | Affiliation | Role |
|---|---|---|
| Omar F Abou Ezzeddine | 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 |
|---|---|
| D006333 | Heart Failure |
| D054144 | Heart Failure, Diastolic |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic 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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| D009750 |
| Nutritional and Metabolic Diseases |
| D017976 |
| Phosphorus Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D017553 | Phosphorus Compounds |
| D017556 | Technetium Compounds |