The CARDIO-TTRansform Scintigraphy Sub-study

N/AActive Not RecruitingNCT06073587

Ionis Pharmaceuticals, Inc.150 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Interventions

Scintigraphy scanDIAGNOSTIC_TEST

Scans will be performed as specified in the arm description.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (5)

Columbia University Irving Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140

The Perugini grading scale visually compares tracer uptake in the myocardium and ribs following injection of the bone tracers (99mTc-DPD, 99mTc-Pyrophosphate \[PYP\], or 99mTc-HMDP). The scale includes 4 grade classifications: Grade 0- no cardiac uptake and normal rib uptake, Grade 1- cardiac uptake which is less than rib uptake, Grade 2- cardiac uptake with intensity similar rib uptake, and Grade 3- cardiac uptake greater than rib uptake with mild or absent rib uptake. Visual scores of 2 or greater are classified as ATTR-positive and less than 2 are interpreted as ATTR-negative.

Time frame: Baseline up to Week 140

Data from ClinicalTrials.gov

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