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临床试验/NCT04700397
NCT04700397Unknown不适用

A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice

National Taiwan University Hospital Hsin-Chu Branch1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
The repeatability and dose response of NTG-Pd/Pa

研究概览

简要总结

Hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.

详细描述

Fractional flow reserve (FFR) is defined as the ratio of mean distal pressure (distal to the target lesion, Pd)to mean proximal pressure (aortic pressure, Pa) in the coronary artery(Pd/Pa) while the maximal hyperemic flow is achieved. Nowadays, FFR-guided PCI is highly recommended for the assessment of physiologic ischemia in intermediate coronary lesions. However, hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Based on the clinical and physiologic outcome study, a lot of non-hyperemic indexes had been proposed, and adenosine injection could be waived. Whereas, these novel physiologic indexes are limited to the proprietary software of each vendor, curtailing clinical application. Intracoronary nitroglycerin injection was needed before each FFR assessment. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.

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

入选标准

  • Eligible for FFR examination

排除标准

  • Hypersensitivity to adenosine or nitroglycerine
  • Severe Valvular aortic stenosis
  • Resting heart rate less than 50 beats per minutes
  • Systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 40 mmHg
  • exposure to PDE-5 inhibitors within 48 hours.
  • Recent intracranial hemorrhage or brain injury

结局指标

主要结局

The repeatability and dose response of NTG-Pd/Pa

时间窗: 10 minutes

Comparing the difference of NTG-Pd/Pa value after various dosage of nitroglycerine injection in the same coronary lesion

次要结局

  • Diagnostic accuracy of NTG-Pd/Pa 2(30 minutes)
  • Diagnostic accuracy of NTG-Pd/Pa 1(30 minutes)
  • Major adverse cardiac event(2 years)

研究者

发起方
National Taiwan University Hospital Hsin-Chu Branch
申办方类型
Other
责任方
Sponsor

研究点 (1)

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