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Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

Primary Purpose

Aortic Stenosis, Transthyretin Amyloidosis, Transthyretin Amyloid Cardiomyopathy

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
99mTc-PYP
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Stenosis

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SPECT/CT

Arm Description

99mTc-PYP single-photon positive emission computed tomography with computed tomography

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
May 19, 2021
Last Updated
July 31, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04899180
Brief Title
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis
Official Title
Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis: A Community Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Transthyretin Amyloidosis, Transthyretin Amyloid Cardiomyopathy, Transthyretin Cardiac Amyloidosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPECT/CT
Arm Type
Other
Arm Description
99mTc-PYP single-photon positive emission computed tomography with computed tomography
Intervention Type
Drug
Intervention Name(s)
99mTc-PYP
Intervention Description
Radioisotope used by SPECT/CT imaging
Primary Outcome Measure Information:
Title
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)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Erickson
Phone
(507) 266-7605
Email
erickson.elizabeth2@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar F Abou Ezzeddine, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Erickson
Phone
507-266-7605
Email
erickson.elizabeth2@mayo.edu
First Name & Middle Initial & Last Name & Degree
Carl Griffin, II
Phone
(507) 255-5690
Email
GriffinII.Carl@mayo.edu

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

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