Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Agreement between SHAPE and pressure catheter measurements
研究概览
简要总结
The fundamental hypothesis of this project is that real-time intracardiac pressures can be monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast echocardiography to assess the accuracy of SHAPE compared to simultaneously acquired intracardiac pressures measured invasively during cardiac catheterization. This study is designed to verify that contrast echocardiography using the SHAPE method, already proven in a canine model and tested in a human pilot study can be used as a surrogate for cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be scheduled for a cardiac catheterization procedure
- •Adult patients over the age of 21
- •Acceptable baseline echocardiographic images in the supine position
- •If a female of child-bearing potential, must have a negative pregnancy test
- •Provide written informed consent
排除标准
- •Clinically unstable patients, e.g., those who are clinically in decompensated heart failure or having active chest pain or presenting for admission with an unstable anginal syndrome
- •Patients in whom introduction of a catheter into the left ventricle is contraindicated or would potentially be dangerous, e.g., patients with active ventricular arrhythmias or with significant aortic valve stenosis where crossing the aortic valve may be difficult and not clinically necessary
- •Patients with anatomic right-to-left, bi-directional, or transient right-to-left cardiac shunts where Definity could traverse as a bolus
- •Patients with known hypersensitivity to Definity
- •Females who are pregnant or nursing
研究组 & 干预措施
Definity for pressure measurements
2 vials of activated Definity mixed with 50 ml saline. As per manufacturer's recommendation the infusion rate may vary between 4-10 ml/min (to provide diagnostic intracardiac contrast visibility).
干预措施: Definity (Drug)
结局指标
主要结局
Agreement between SHAPE and pressure catheter measurements
时间窗: up to 1 day
Correlation
Error between SHAPE and pressure catheter measurements
时间窗: up to 1 day
ANOVA/Post-hoc comparisons
次要结局
未报告次要终点
研究者
Jaydev Dave
Assistant Professor
Thomas Jefferson University