Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

  • STATUS
    Recruiting
  • End date
    Aug 20, 2024
  • participants needed
    200
  • sponsor
    Mayo Clinic
Updated on 7 October 2022
stenosis

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.

Details
Condition Aortic Stenosis, Transthyretin Amyloidosis, Transthyretin Amyloid Cardiomyopathy, Transthyretin Cardiac Amyloidosis
Treatment 99mTc-PYP
Clinical Study IdentifierNCT04899180
SponsorMayo Clinic
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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