Trials / Completed
CompletedNCT04899180
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis: A Community Study
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
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).
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 99mTc-PYP | Radioisotope used by SPECT/CT imaging |
Timeline
- Start date
- 2023-07-14
- Primary completion
- 2024-01-05
- Completion
- 2024-01-05
- First posted
- 2021-05-24
- Last updated
- 2024-08-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04899180. Inclusion in this directory is not an endorsement.