Transthyretin Amyloid Cardiomyopathy Clinical Trial
The CARDIO-TTRansform Scintigraphy Sub-study
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 treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.
Full 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 optional scintigraphy scans.
Eligibility Criteria
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.
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There are 5 Locations for this study
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Majadahonda , 28222, Spain
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