Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT)
Observational Study of the Evaluation of FFR in the Treatment of Coronary Artery Disease
Functional evaluation of coronary lesions, through the evaluation of fractional flow reserve (FFR) with pressure-wire in patients with coronary artery disease (CAD) was evaluated in a randomised trial - the FAME trial - where it was showed to be superior to classic anatomical evaluation. Based on these results, current guidelines recommend the use of FFR (class I-A recommendation) when objective evidence of vessel-related ischemia is not available. Since the FAME trial was published, FFR use increased dramatically in most European countries, Portugal being no exception to this trend. FFR is currently being used in many interventional cardiology centres quite beyond the European Guidelines recommendation, since many physicians now trust more on the information they can collect with pressure-wire during the angiography, and less on non invasive imaging stress tests.
Considering this widespread use of FFR in the evaluation of patients with CAD, there is a need to clarify the clinical results of this approach in a "real patient setting". The Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT) was planned to evaluate if the use of FFR in the decision of coronary revascularization is feasible and allows optimized clinical results in "real world" non selected patients, as showed in clinical randomised trials.
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Coimbra、葡萄牙、3000-306
- CNCDC
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- consecutive CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation).
Exclusion Criteria:
- Patient not willing to participate (informed consent not signed).
- Life expectancy lower than 12 months (due to cardiac or non-cardiac disease)
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Fractional Flow Reserve
Coronary artery disease patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation).
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CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation)
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Major adverse cardiac events
大体时间:One Year
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Combined endpoint of major adverse cardiac events (cardiovascular mortality, myocardial infarction and coronary revascularization)
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One Year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cardiovascular mortality
大体时间:One Year
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Cardiovascular mortality at one year
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One Year
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Myocardial infarction
大体时间:One year
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Rate of Myocardial infarction at one year
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One year
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Coronary revascularization
大体时间:One year
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Unplanned coronary revascularization at one year
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One year
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Impact of FFR in the clinical decision
大体时间:During the procedure
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Impact (change in the original strategy) of FFR in the clinical decision of interventional cardiologists
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During the procedure
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Mismatch between non invasive imaging stress tests and FFR
大体时间:During the procedure
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Mismatch between non invasive imaging stress tests and functional evaluation with FFR in a "real world" (not selected) setting
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During the procedure
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合作者和调查者
调查人员
- 首席研究员:Sergio B Baptista, MD、Hospital Fernando Fonseca, Amadora, Portugal
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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