Clinical Trial
Study Details
Status
RECRUITING
Study ID #
NCT04899180
Study Start
Primary Completion
Study Completion
Enrollment
200
Study Type
Interventional
Phase
Early Phase 1
Interventions
99mTc-PYP

Radioisotope used by SPECT/CT imaging

Primary Outcomes
Measure
Prevalence of TTR-CA in patients with moderate and severe aortic stenosis
Description

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)

Timeframe
Baseline
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 single-photon positive emission computed tomography with computed tomography (SPECT/CT).

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 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.

Conditions
Aortic Stenosis
Transthyretin Amyloidosis
Transthyretin Amyloid Cardiomyopathy
Transthyretin Cardiac Amyloidosis
Study Contact
Name
Elizabeth Erickson
Role
Contact
Phone
(507) 266-7605
Email
erickson.elizabeth2@mayo.edu
Locations
Facility

Mayo Clinic in Rochester
Rochester, MN 55905
United States

Contacts
Study Contact
Name
Carl Griffin, II
Phone
(507) 255-5690
Email
GriffinII.Carl@mayo.edu
Role
Contact
Eligibility Criteria

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:

* Moderate AS: 1.0 cm2 \< aortic valve area (AVA) ≤ 1.5 cm2
* Severe AS: AVA ≤ 1.0 cm2

Exclusion Criteria:

* 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)

Eligibility Minimum Age
75 Years
Sexes Eligible for Study
ALL
Eligibility Std Ages
Older Adult