Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis
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
🗓️ Study Start (Actual) 14 July 2023
🗓️ Primary Completion (Estimated) August 2024
✅ Study Completion (Estimated) August 2024
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 75 Years to N/A (OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 May 2021
  • First Submitted that Met QC Criteria 19 May 2021
  • First Posted 24 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 July 2023
  • Last Update Posted 2 August 2023
  • Last Verified July 2023