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CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study

Active Not RecruitingN/A

Sponsor: Ionis Pharmaceuticals, Inc.

Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Interventions: Cardiac MRI

Countries: United States, Italy, Spain, United Kingdom

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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).

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.

Locations (11)

Boston, Massachusetts, United States
Portland, Oregon, United States
Florence, Italy
Padova, Italy
Majadahonda, Spain
Bellshill, United Kingdom
Birmingham, United Kingdom
Cardiff, United Kingdom
London, United Kingdom
London, United Kingdom
Manchester, United Kingdom