Evaluation of the Effect of T3US on Myocardial Blow Flow in the Hibernating
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in myocardial blood flow from baseline to post ultrasound treatment
研究概览
简要总结
The purpose of this study is to evaluate whether the use application of low frequency ultrasound, administered by the Timi3 ultrasound device, increases myocardial blood flow to the heart, in subjects with reduced myocardial blood flow at rest (hibernating myocardium). The primary endpoint of the trial is to assess the increase in myocardial blood flow from baseline to post Timi3 Ultrasound treatment in a hypoperfused region of myocardium. Positron emission tomography (PET) imaging will be used to noninvasively evaluate cardiac blood flow. The hypothesis is that ultrasound increases blood flow in hibernating myocardium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Must have reversible resting ischemia, resting non-reversible blood flow defect, or stress-induced ischemia.
- •Females with childbearing potential must not be pregnant at the time of the study
- •Must provide written informed consent
排除标准
- •Unable or unwilling to cooperate with study procedures
- •Currently enrolled in another clinical study for which the follow-up period is not complete
结局指标
主要结局
Change in myocardial blood flow from baseline to post ultrasound treatment
时间窗: immediate post treatment
次要结局
未报告次要终点
