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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Coimbra、ポルトガル、3000-306
- CNCDC
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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)
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major adverse cardiac events
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cardiovascular mortality
時間枠:One Year
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Cardiovascular mortality at one year
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One Year
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Myocardial infarction
時間枠: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
時間枠:One year
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Unplanned coronary revascularization at one year
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One year
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Impact of FFR in the clinical decision
時間枠: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
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Sergio B Baptista, MD、Hospital Fernando Fonseca, Amadora, Portugal
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。