A Prospective, Multicenter Study: Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value
研究概览
简要总结
The goal of this observational study is to compare the value of NTG-Pd/Pa and saline-Pd/Pa in participants with intermediate stenosis of the coronary artery. The main questions it aims to answer are:
The numerical difference between NTG-Pd/Pa and saline-Pd/Pa To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment?
Participants will undergo NTG-Pd/Pa, Saline-Pd/Pa, and FFR successively in the target vessel.
详细描述
Fractional Flow Reserve (FFR) is the gold standard for determining the functional ischemia of coronary arteries with intermediate lesions. Both intracoronary nitroglycerine (NTG) administration and saline administration induce an acute drop in trans-lesional coronary pressure. Both pressure ratios correlate well with FFR values and can reliably predict positive results in FFR assessments. The aims of this study were
- To evaluate the numerical difference between NTG-Pd/Pa and saline-Pd/Pa.
- To test the repeatability of saline-Pd/Pa.
- To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment.
Participants will be enrolled prospectively from National Taiwan University Hospital Hsinchu Hospital, Miaoli General Hospital, and Taichung Veterans General Hospital. The coronary artery with intermediate stenosis will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with coronary artery with 50-90% stenosis.
- •In participants who suffered from ST elevation myocardial infarction within 5 days, only the non-culprit vessel was eligible for coronary functional testing.
排除标准
- •Systolic blood pressure is less than 90 mmHg for more than 5 minutes during examination.
- •Resting heart rate is less than 50 beats per minute.
- •Heart failure remains decompensated at the time of examination, such as inability to lie flat or cardiogenic shock.
- •Acute onset of asthma or chronic obstructive pulmonary disease.
结局指标
主要结局
Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value
时间窗: 3 minutes
The absolute difference was calculated as the Saline-Pd/Pa value minus the NTG-Pd/Pa value.
次要结局
- Repeatability of Saline-Pd/Pa(2 minutes)
- Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa(4 minutes)