Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis

NCT04899180 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 20-004778
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Stenosis; Transthyretin Amyloidosis; Transthyretin Amyloid Cardiomyopathy; Transthyretin Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SPECT/CT

OTHER

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

Drug: 99mTc-PYP

Interventions

99mTc-PYP DRUG

Radioisotope used by SPECT/CT imaging

SPECT/CT

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Aortic Valve Stenosis; Amyloidosis, Hereditary, Transthyretin-Related

Interventions

Technetium Tc 99m Pyrophosphate

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Diphosphates; Polyphosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Phosphorus Compounds; Technetium Compounds

Study Officials

• Omar F Abou Ezzeddine, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: July 14, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

US (1)