NCT06332131Enrolling By Invitation不适用
Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of new abnormal myocardial blood flow reserve (MBFR)
研究概览
简要总结
This is an observational study that includes patients with breast cancer or non-small cell lung cancer who will be treated with immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Either diagnosis of breast cancer with plan for treatment according to the Keynote 522 regimen or non-small-cell lung cancer planned for neoadjuvant treatment that includes pembrolizumab
- •Able to provide written informed consent
排除标准
- •Pregnant or breast-feeding:
- •Prior treatment with ICI therapy.
- •Vulnerable patients, including pregnant women and prisoners
- •Absolute Contraindication to rest/vasodilator stress PET/CT
结局指标
主要结局
Incidence of new abnormal myocardial blood flow reserve (MBFR)
时间窗: 3 months
Development of MBFR\<2
次要结局
- Incidence of major cardiovascular events(3 months)
- Coronary calcium score(3 month)
- All cause mortality(3 months)
- Cardiovascular specific mortality(3 months)
研究者
研究点 (1)
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