carDIo-ttranSSfOrm nucLEar Imaging Study
The investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (Tc-99m PYP) tracer on serial planar and SPECT imaging in patients enrolled in the CARDIO-TTRansform clinical trial (NCT04136171).
Conditions:
🦠 Amyloidosis 🦠 Transthyretin Amyloid Cardiomyopathy
🗓️ Study Start (Actual) 19 January 2022
🗓️ Primary Completion (Estimated) 30 December 2025
✅ Study Completion (Estimated) 30 December 2026
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Portland, Oregon, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients who were screened and eligible to be enrolled or have been already enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) and have a baseline 99m-technetium pyrophosphate planar and SPECT imaging done within 12 months prior to screening for CARDIO-TTRansform.
    • * Patients have to meet the inclusion and exclusion criteria of CARDIO-TTRansform trial to be enrolled.
    • * Patient willing to consent for the study and undergo the study procedures.

    Exclusion Criteria:

    • * None
Ages Eligible for Study: 60 Years to 90 Years (ADULT, 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 17 February 2022
  • First Submitted that Met QC Criteria 17 February 2022
  • First Posted 28 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 February 2022
  • Last Update Posted 28 February 2022
  • Last Verified February 2022