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Status:

ACTIVE_NOT_RECRUITING

The CARDIO-TTRansform Scintigraphy Sub-study

Lead Sponsor:

Ionis Pharmaceuticals, Inc.

Collaborating Sponsors:

AstraZeneca

Conditions:

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Eligibility:

All Genders

18-90 years

Brief Summary

The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after tre...

Detailed Description

Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optiona...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Participants must have been properly randomized into the ION-682884-CS2 study (NCT04136171) and should have had a baseline scintigraphy scan (99mTc-DPD, 99mTc- PYP, and 99mTc-HMDP) within 12 months prior to screening for ION-682884-CS2 with planar and SPECT or SPECT/CT images that can be read by the central reader.
  • Exclusion criteria:
  • Must not meet any of the exclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
  • Must not have weight or body girth that exceeds the limits of the equipment specifications.
  • Should not have any previously reported hypersensitivity reaction to Technetium-99m.

Exclusion

    Key Trial Info

    Start Date :

    April 4 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2026

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT06073587

    Start Date

    April 4 2023

    End Date

    March 1 2026

    Last Update

    November 28 2025

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Columbia University Irving Medical Center

    New York, New York, United States, 10032

    2

    Duke University Medical Center

    Durham, North Carolina, United States, 27710

    3

    Cleveland Clinic Main Campus

    Cleveland, Ohio, United States, 44195

    4

    Oregon Health and Science University

    Portland, Oregon, United States, 97239