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The CARDIO-TTRansform Scintigraphy Sub-study

Active, not recruiting
Conditions
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Registration Number
NCT06073587
Lead Sponsor
Ionis Pharmaceuticals, Inc.
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 treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.

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 optional scintigraphy scans.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
150
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 Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140Baseline up to 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (5)

Columbia University Irving Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

New York, New York, United States

Duke University Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Durham, North Carolina, United States

Cleveland Clinic Main Campus

๐Ÿ‡บ๐Ÿ‡ธ

Cleveland, Ohio, United States

Oregon Health and Science University

๐Ÿ‡บ๐Ÿ‡ธ

Portland, Oregon, United States

Hospital Universitario Puerta de Hierro

๐Ÿ‡ช๐Ÿ‡ธ

Majadahonda, Spain

Columbia University Irving Medical Center
๐Ÿ‡บ๐Ÿ‡ธNew York, New York, United States

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