Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

Aortic Stenosis Clinical Trial

Official title:

Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis: A Community Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899180
• Other study ID #: 20-004778
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 14, 2023
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: Elizabeth Erickson
• Phone: (507) 266-7605
• Email: erickson.elizabeth2[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amyloidosis
• Aortic Stenosis
• Aortic Valve Stenosis
• Cardiomyopathies
• Constriction, Pathologic
• Transthyretin Amyloid Cardiomyopathy
• Transthyretin Amyloidosis
• Transthyretin Cardiac Amyloidosis

Intervention

Drug:
• 99mTc-PYP
Radioisotope used by SPECT/CT imaging

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of TTR-CA in patients with moderate and severe aortic stenosis	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)	Baseline

External Links

•   Mayo Clinic Clinical Trials