Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-004778
NCT ID: NCT04899180
About this study
The purpose of this study is to determine the prevalence of TTR-CA in a community-based cohort of moderate and severe aortic stenosis patients using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County).
- Age ≥ 75 years old.
- Current diagnosis of moderate or severe aortic stenosis by most recent (within 6 months at most) echocardiogram as defined by:
- Moderate Aortic Stenosis (AS): 1.0 cm^2 < aortic valve area (AVA) ≤ 1.5 cm^2;
- Severe AS: AVA ≤ 1.0 cm^2.
Exclusion Criteria:
- Any cardiac surgery or major chest trauma within 4 weeks of pyrophosphate (PYP) scan (or myocardial infarct imaging).
- Myocardial infarction within 4 weeks of PYP scan defined by typical angina, EKG changes and significant change in serial troponins.
- Note that chronic troponin elevation is extremely common in cardiac amyloidosis.
- Prior or current exposure to Plaquenil (Hydroxychloroquine).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available