Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04899180
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2021-05-19
Brief Title:
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis A Community Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 single-photon positive emission computed tomography with computed tomography SPECTCT
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 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 SPECTCT imaging to rule inout 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None