Assessment of the Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home.
研究概览
简要总结
The clinical trial compares the reproducibility and accuracy of cardiac tonometry-based portable systems that may detect early cardiac dysfunction (SphygmoCor® Xcel and Oscar 2™ ambulatory blood pressure monitor) at home and in the clinic to currently available screening tests for heart failure including echocardiogram (echo) and cardiovascular magnetic resonance (CMR). The SphygmoCor® Xcel and Oscar 2™ systems may help detect cardiac dysfunction earlier than other available screening tests because it can be self-administered outside of the clinic. This study aims to test the accuracy and practicality of these devices in the clinic setting and at home.
详细描述
Primary Objective(s)
Validate the accuracy of ejection fraction, as measured using a tonometry-based system (SphygmoCor® Xcel), in the clinic setting, and determine the reproducibility (Oscar 2™) at home.
Secondary Objective(s)
Determine the cost-effectiveness of tonometry-based screening in the clinic setting and at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously enrolled in IRB#
- •Able to understand and sign the study specific informed consent form (ICF).
排除标准
- •Participants cannot be actively receiving cancer-directed therapy.
- •Standard exclusion criteria for CMR imaging will be incorporated, and these include: implanted pacemaker or defibrillator, insulin pump, cochlear implant, central nervous system aneurismal clips, implanted neural stimulator, ocular foreign body (metal), other implanted medical devices (e.g.: drug infusion ports).
结局指标
主要结局
Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home.
时间窗: Up to 2 years
Validate the accuracy of ejection fraction, as measured using a tonometry-based system (SphygmoCor® Xcel), in the clinic setting, and determine the reproducibility (Oscar 2™) at home.
次要结局
- Cost-effectiveness of tonometry-based screening in the clinic setting and at home.(Up to 2 years)