The CARDIO-TTRansform Scintigraphy Sub-study
CARDIO-TTRansform ION-682884-CS2-Scintigraphy Sub-study
3 other identifiers
observational
163
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2023
CompletedFirst Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2026
CompletedSeptember 11, 2026
September 1, 2026
3 years
October 4, 2023
September 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to Week 140
Study Arms (1)
ION-682884-CS2 Scintigraphy Subset
Participants randomized in ION-682884-CS2 (NCT04136171) study to receive either eplontersen or placebo with baseline scintigraphy scan with planar and single-photon emission computerized tomography (SPECT) or SPECT with computed tomography (SPECT/CT) images will undergo an optional scintigraphy scan at Weeks 25 or 37, Week 97, and an additional scan at Week 140.
Interventions
Scans will be performed as specified in the arm description.
Eligibility Criteria
Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and who signed informed consent for the Scintigraphy sub-study will participate in this sub-study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ionis Pharmaceuticals, Inc.lead
- AstraZenecacollaborator
Study Sites (5)
Columbia University Irving Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Hospital Universitario Puerta de Hierro
Majadahonda, 28222, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 10, 2023
Study Start
April 4, 2023
Primary Completion
March 25, 2026
Study Completion
March 25, 2026
Last Updated
September 11, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.