The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI, a Non-Invasive, Functional Respiratory Imaging System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Ratio of BV5A to BV10A
研究概览
简要总结
Explore the impact of drug candidate CS1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (PAH). This sub-study for CS1-004 aims to utilize FRI, an innovative, non-invasive imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This sub-study seeks to provide valuable insights into the potential of CS1 to transform PAH treatment in some patients enrolled in the Expanded Access Program (CS1-004).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the CS1-004 clinical trial
排除标准
- •Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia)
- •Individuals who are pregnant or who become pregnant during the sub-study
- •eGFR <30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD)
- •Allergy to Iodine contrast agents
研究组 & 干预措施
CT Pulmonary Angiography Recipient
All subjects in this study will undergo CT pulmonary angiography scans at baseline (+/- 2 months from start of drug therapy), 4 months and 12 months.
干预措施: CT Pulmonary Angiography Scan (Diagnostic Test)
结局指标
主要结局
Ratio of BV5A to BV10A
时间窗: From baseline CT scan to 12 month CT scan
Change from baseline to month 12 in the ratio BV5A/BV10A
次要结局
- Ratio of BV5A to BV5APR(From baseline CT scan to 12 month CT scan)
- Ratio of BV5A to BV5APRA(From baseline CT scan to 12 month CT scan)