Status:
COMPLETED
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis
Lead Sponsor:
Mayo Clinic
Conditions:
Aortic Stenosis
Transthyretin Amyloidosis
Eligibility:
All Genders
75+ years
Phase:
EARLY_PHASE1
Brief Summary
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 si...
Detailed Description
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 revi...
Eligibility Criteria
Inclusion
- 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:
- Moderate AS: 1.0 cm2 \< aortic valve area (AVA) ≤ 1.5 cm2
- Severe AS: AVA ≤ 1.0 cm2
Exclusion
- Any cardiac surgery or major chest trauma within 4 weeks of PYP scan
- 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)
Key Trial Info
Start Date :
July 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04899180
Start Date
July 14 2023
End Date
January 5 2024
Last Update
August 7 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905