The Safety and Efficacy of FFR Protocol in NTUH System
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 27, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | October 3, 2018 | ||
| 预计主要完成日期 | December 31, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Adenosine related adverse event[ Time Frame: 24 hours ] Including Bradyarrhythmia including sinus pause and transient AV block Acute respiratory failure define by respiratory distress which need mechanical ventilator support Major adverse cardiac event (MACE)[ Time Frame: 2 year ] MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | The Safety and Efficacy of FFR Protocol in NTUH System | ||
| 正式标题 ICMJE | The Safety and Efficacy of Current FFR Measurement in NTUH Health Care System | ||
| 简要概况 | FFR has been introduced for determination of physiological ischemia in myocardium for many years. Nowadays, FFR-guided PCI is highly recommended for 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) 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. |
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| 详细说明 | |||
| 研究类型 ICMJE | Observational [Patient Registry] | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational [Patient Registry] 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
250 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 31, 2022 | ||
| 预计主要完成日期 | December 31, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Eligible for FFR examination Exclusion Criteria: - Hypersensitivity to adenosine - Severe valvular aortic stenosis - Resting heart rate less than 50 beats per minute | ||
| 性别 |
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| 年龄 | 最小年龄：20 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | National Taiwan University Hospital Hsin-Chu Branch | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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