NCT02300870终止不适用
Myocardial Perfusion Echocardiography to Detect Human Heart Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Global and regional microvascular myocardial perfusion
研究概览
简要总结
The primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital
排除标准
- •hemodynamic instability (e.g., systolic blood pressure < 90 mmHg)
- •atrial fibrillation with rapid ventricular response (e.g., heart rate > 120 bpm)
- •premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment
- •poor acoustic windows
- •inability to provide informed consent
- •any contraindication listed in the Optison package insert (i.e., history of an allergic reaction)
研究组 & 干预措施
Heart Transplant Rejection
Patients presenting with acute cellular rejection
干预措施: Optison (Drug)
Heart Transplant Control
Patients presenting for routine office visit
干预措施: Optison (Drug)
结局指标
主要结局
Global and regional microvascular myocardial perfusion
时间窗: Baseline
Myocardial blood flow (dB/s)
次要结局
未报告次要终点
研究者
Michael Givertz, MD
Medical Director, Heart Transplant and Mechanical Circulatory Support
Brigham and Women's Hospital
研究点 (1)
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