The Safety and Efficacy of Current FFR Measurement in NTUH Health Care System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Adenosine related adverse event
研究概览
简要总结
FFR-guided PCI has been performed in National Taiwan University Hospital(NTUH) for many years. Nevertheless, the method of FFR measurement in NTUH is different from that in literature. In this study, the investigator would like to evaluate the effectiveness and safety of NTUH experience in FFR prospectively. First, the investigator will record any intracoronary (IC) injected adenosine-related complications, such as bradyarrhythmia or chest discomfort. Second, the investigator will follow up on the clinical outcome of the participants for 2 years, record if any target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death. Finally, left ventricular diastolic pressure, serum pro-brain natriuretic peptide (pro-BNP), and high sensitivity C- reactive protein (hsCRP) will be checked and determined their relationships with the maximum dosage of IC adenosine.
详细描述
FFR has been introduced for the determination of physiological ischemia in the myocardium for many years. Nowadays, FFR-guided PCI is highly recommended for the assessment of physiologic ischemia in intermediate coronary lesions. FFR-guided PCI has been performed in National Taiwan University Hospital(NTUH) for many years. Nevertheless, the method of FFR measurement in NTUH is different from that in literature. In this study, the investigator would like to evaluate the effectiveness and safety of NTUH experience in FFR prospectively. First, the investigator will record any intracoronary (IC) injected adenosine-related complications, such as bradyarrhythmia or chest discomfort. Second, the investigator will follow up on the clinical outcome of the participants for 2 years, record if any target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death. Finally, left ventricular diastolic pressure, serum pro-brain natriuretic peptide (pro-BNP), and high sensitivity C- reactive protein (hsCRP) will be checked and determined their relationships with the maximum dosage of IC adenosine.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for FFR examination
排除标准
- •Hypersensitivity to adenosine
- •Severe valvular aortic stenosis
- •Resting heart rate less than 50 beats per minute
结局指标
主要结局
Adenosine related adverse event
时间窗: 24 hours
Including 1. Bradyarrhythmia including sinus pause and transient AV block 2. Acute respiratory failure define by respiratory distress which need mechanical ventilator support
Major adverse cardiac event (MACE)
时间窗: 2 year
MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death
次要结局
- The relationship between left ventricular diastolic pressure and maximum dosage of IC adenosine(1 hour)