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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06073574
Registration number
NCT06073574
Ethics application status
Date submitted
4/10/2023
Date registered
10/10/2023
Date last updated
10/10/2023
Titles & IDs
Public title
CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
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Scientific title
The CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
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Secondary ID [1]
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2019-002835-27
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Secondary ID [2]
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ION-682884-CS2MRI
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Cardiac MRI
Experimental: ION-682884-CS2 MRI Scan Sub-set - Participants enrolled in the parent study ION-682884-CS2 (NCT04136171) to receive either eplontersen or placebo and who consented to participate in this sub-study will undergo cardiac MRI at Baseline, Weeks 25, 49, 97 and 140.
Diagnosis / Prognosis: Cardiac MRI
MRI Scans as specified in the corresponding arm group.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups
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Assessment method [1]
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Timepoint [1]
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From Baseline up to Week 140
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Eligibility
Key inclusion criteria
To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion
criteria of the study protocol ION-682884-CS2 (NCT04136171).
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. Contraindication or sensitivity to MRI contrast agents
2. Orthopnea of sufficient severity to preclude supine scanning at screening.
3. Weight or body girth exceeds the limits of the cardiac MRI machine specifications.
4. Contraindication to cardiac MRI scanning, as assessed by local MRI safety
questionnaire/checklist.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2026
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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United States of America
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Oregon
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Italy
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Florence
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Italy
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Padova
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Spain
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Majadahonda
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United Kingdom
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State/province [6]
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Bellshill
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Country [7]
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United Kingdom
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State/province [7]
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Birmingham
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United Kingdom
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Cardiff
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United Kingdom
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London
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Country [10]
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United Kingdom
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State/province [10]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Ionis Pharmaceuticals, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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AstraZeneca
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to measure the amyloid burden, defined as extracellular
volume (ECV) assessed by Magnetic Resonance Imaging (MRI) over time in a subset of up to 150
participants enrolled in ION-682884-CS2 (NCT04136171).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06073574
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06073574
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