The CARDIO-TTRansform Scintigraphy Sub-study
- 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
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140 Baseline 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
Name Time Method
Trial Locations
- Locations (5)
Columbia University Irving Medical Center
๐บ๐ธNew York, New York, United States
Duke University Medical Center
๐บ๐ธDurham, North Carolina, United States
Cleveland Clinic Main Campus
๐บ๐ธCleveland, Ohio, United States
Oregon Health and Science University
๐บ๐ธPortland, Oregon, United States
Hospital Universitario Puerta de Hierro
๐ช๐ธMajadahonda, Spain
Columbia University Irving Medical Center๐บ๐ธNew York, New York, United States