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Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT)

2015年5月22日 更新者:Portuguese Society of Cardiology

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

Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT9 is a national multicentric, prospective, consecutive (non selected) anonymous observational study of all patients submitted to coronary angiography and in which functional evaluation with pressure-wire of coronary lesions is to be performed. The main purpose of the registry is to collect data on the medical decisions and clinical results in CAD patients evaluated with FFR (using pressure-wire®, St. Jude Medical), in order to provide evidence in "real world" non selected patients. This evidence will add to the already available clinical data from randomized trials. All Portuguese interventional cardiology centers performing regularly FFR studies were invited to participate in the study. Data will be collected at the time of the procedure and patients will be clinically followed-up for 1 year. Information concerning medical history, past exams, the angiography, the FFR study and the follow-up will be collected on registry forms. The treatment strategy for each patient will be decided by the operator physician, according to his best clinical judgment. Changes in treatment strategy due to FFR results will be recorded, but the intention of the study is just to collect clinical information, and not to influence physician practice. An informed consent form must be signed for all patients included. Patients will be free to withdraw this consent at anytime.

研究类型

观察性的

注册 (实际的)

918

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Coimbra、葡萄牙、3000-306
        • CNCDC

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

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

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Consecutive CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation).

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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).
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:
  • Pressure-Wire (St. Jude Medical)

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
Major adverse cardiac events
大体时间:One Year
Combined endpoint of major adverse cardiac events (cardiovascular mortality, myocardial infarction and coronary revascularization)
One Year

次要结果测量

结果测量
措施说明
大体时间
Cardiovascular mortality
大体时间:One Year
Cardiovascular mortality at one year
One Year
Myocardial infarction
大体时间:One year
Rate of Myocardial infarction at one year
One year
Coronary revascularization
大体时间:One year
Unplanned coronary revascularization at one year
One year

其他结果措施

结果测量
措施说明
大体时间
Impact of FFR in the clinical decision
大体时间:During the procedure
Impact (change in the original strategy) of FFR in the clinical decision of interventional cardiologists
During the procedure
Mismatch between non invasive imaging stress tests and FFR
大体时间:During the procedure
Mismatch between non invasive imaging stress tests and functional evaluation with FFR in a "real world" (not selected) setting
During the procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年3月1日

初级完成 (实际的)

2013年11月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2013年4月16日

首先提交符合 QC 标准的

2013年4月18日

首次发布 (估计)

2013年4月19日

研究记录更新

最后更新发布 (估计)

2015年5月25日

上次提交的符合 QC 标准的更新

2015年5月22日

最后验证

2015年5月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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