The CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 22
- 主要终点
- Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups
研究概览
简要总结
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).
详细描述
This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
排除标准
- •Contraindication or sensitivity to MRI contrast agents
- •Orthopnea of sufficient severity to preclude supine scanning at screening.
- •Weight or body girth exceeds the limits of the cardiac MRI machine specifications.
- •Contraindication to cardiac MRI scanning, as assessed by local MRI safety questionnaire/checklist.
研究组 & 干预措施
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.
干预措施: Cardiac MRI (Diagnostic Test)
结局指标
主要结局
Change in the Percent of ECV in Participants Receiving ION-682884 vs. Placebo According to ION-682884-CS2 Treatment Groups
时间窗: From Baseline up to Week 140
次要结局
未报告次要终点