Vascular Cardiotoxicity of Ponatinib
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Carotid plaque size
研究概览
简要总结
Pre-clinical studies suggest that the third generation tyrosine kinase inhibitor ponatinib can result in microvascular angiopathy and acceleration of atherosclerosis. This study is intended to examine for myocardial microvascular angiopathy and changes in carotid plaque in patients receiving ponatinib as part of their clinical care.
详细描述
In this study, we will perform serial echocardiography for ventricular function, myocardial contrast echocardiography for microvascular perfusion assessment, blood analysis for myocardial injury, and carotid US for plaque or IMT progression in subjects receiving ponatinib. This series of tests is intended to provide information on the presence of clinically-evident or subclinical microvascular angiopathy and plaque acceleration.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CML or ALL
- •Prescribed ponatinib
排除标准
- •pregnancy or lactation
- •major medical illness involving the heart or vasculature (CAD, PAD, DCM).
- •hemodynamically unstable
- •allergy to ultrasound contrast agents.
结局指标
主要结局
Carotid plaque size
时间窗: 12 months
Changes in IMT or plaque size
Presence versus absence of any myocardial perfusion defect assessed by visual analysis for any abnormalities of microvascular flux rate (beta function) or microvascular blood volume during an infusion of ultrasound microbubble contrast agents.
时间窗: 12 months
Contrast ultrasound perfusion imaging will be performed using power-modulation imaging and infusion of an ultrasound contrast agent. Destruction replenishment kinetics will be assessed visually by examination of delayed replenishment of signal intensity (\>5 seconds) after a high-mechanical index burst sequence, or abnormalities in plateau intensity reflecting regional abnormalities in myocardial microvascular blood volume.
次要结局
未报告次要终点
研究者
Jonathan R. Lindner, MD
Assistant Professor
Oregon Health and Science University