Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. (CompareAcute)
Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.
Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.
Approximately 885 patients will be entered in the study.
Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.
調査の概要
状態
詳細な説明
Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.
Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines
Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)
Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.
Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines
Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Arnhem、オランダ
- Rijnstate Hospital
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Groningen、オランダ
- University Medical Center Groningen
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Heerlen、オランダ
- Atrium MC Parkstad
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Maastricht、オランダ
- Maastricht Universitair Medical center
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Rotterdam、オランダ、3079DZ
- Maasstadhospital
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The Hague、オランダ、2512 VA
- Medisch Centrum Haaglanden
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Singapore、シンガポール、308433
- Tan Tock Seng Hospital
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Singapore、シンガポール、768828
- Khoo Teck Puat Hospital
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Goteborg、スウェーデン、41315
- Sahlgrenska Götheborg University Hospital
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Brno、チェコ
- University Hospital Brno
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Hradec Králové、チェコ
- University Hospital Hradec Kralove
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Liberec、チェコ
- Liberec Regional Hospital
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Bad Krozingen、ドイツ、79189
- Herz-Zentrum Bad Krozingen
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Bad Segeberg、ドイツ、23795
- Herzzentrum Bad Segeberger Klinik
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Bremen、ドイツ、28277
- Klinikum Links der Weser
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Ingolstadt、ドイツ、85049
- Medizinische Klinik IV
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Rostock、ドイツ、18057
- Medical University Rostock
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Oslo、ノルウェー
- Oslo University Hospital
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Budapest、ハンガリー
- Gottsegen György Országos Kardiológiai Intézet
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Nyíregyháza、ハンガリー
- Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital
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Szeged、ハンガリー
- Szent-Györgyi Albert Klinika
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Zalaegerszeg、ハンガリー
- Zala Megyei Kórház
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Lubin、ポーランド
- Miedziowe Centrum Zdrowia Lubin
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Warsaw、ポーランド
- Centralny Szpital Kliniczny MSWiA w Warszawie
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Warsaw、ポーランド
- Kliniki Kardiologii Allenort
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Wroclaw、ポーランド
- 4 Wojskowy Szpital Kliniczny Z Poliklinika SP ZOZ
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
- Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised
Exclusion Criteria:
- Left main stem disease (stenosis > 50%)
- STEMI due to in-stent thrombosis
- Chronic total occlusion of a non-IRA
- Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
- Non-IRA stenosis not amenable for PCI treatment (operators decision)
Complicated IRA treatment, with one or more of the following;
- Extravasation,
- Permanent no re-flow after IRA treatment (TIMI flow 0-1),
- Inability to implant a stent
- Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
- Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
- Life expectancy of < 2 years.
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
- Gastrointestinal or genitourinary bleeding within the prior 3 months,
- Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Pregnancy or planning to become pregnant any time after enrolment into this study.
- Inability to obtain informed consent.
- Expected lost to follow-up.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：FFR-guided revascularisation strategy
In the FFR-group all flow limiting (FFR≤0.80)
lesions will receive treatment by PCI and stenting.
The non-IRA PCI should be performed during the same intervention.
Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient.
Such procedures can be performed in a second procedure which should take place within the same hospitalisation.
All lesions with a FFR measurement of >0.80 will not be treated.
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FFR-guided revascularisation strategy
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プラセボコンパレーター：randomised to guidelines group
In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place.
The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).
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Staged revascularisation by proven ischemia or persistence of symptoms of angina
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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 |
|---|---|---|
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Number of Participants With the Composite Endpoint of MACCE
時間枠：12 months
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Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
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12 months
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Number of Participants With Death From Any Cause
時間枠：12 months
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Number of participants with all cause mortality at 12 months between groups
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12 months
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Number of Participants With Cardiac Death
時間枠：12 months
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Number of participants with Cardiac mortality at 12 months between groups
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12 months
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Number of Participants With Spontaneous MI
時間枠：12 months
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Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
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12 months
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Number of Participants With Periprocedural MI
時間枠：12 months
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Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
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12 months
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Number of Participants With Revascularization - PCI
時間枠：12 months
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Number of participants with revascularization PCI at 12 months between groups
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12 months
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Number of Participants With Revascularization - CABG
時間枠：12 months
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Number of participants with revascularization CABG at 12 months between groups
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12 months
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Number of Participants With Cerebrovascular Event
時間枠：12 months
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Number of participants with Cerebrovascular event at 12 months between groups
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12 months
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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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Number of Participants With Composite Endpoint of NACE (Any First Event)
時間枠：12 months
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Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e.
Net Adverse Clinical Events)
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12 months
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Number of Participants With Death From Any Cause or MI
時間枠：12 months
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Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months
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12 months
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Number of Participants With Major Bleeding
時間枠：12 months
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Number of participants with Major bleeding at 12 months - Part of composite NACE
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12 months
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Number of Participants With Any Bleeding at 12 Months
時間枠：12 months
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Number of participants with any bleeding at 12 months - part of composite endpoint NACE
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12 months
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Number of Participants With Any Bleeding at 48 Hours
時間枠：48 hours
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Number of participants with any bleeding at 48 hours - part of composite endpoint NACE
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48 hours
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Number of Participants With Hospitalization
時間枠：12 months
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Number of participants with hospitalization for heart failure, unstable angina or chest pain
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12 months
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Number of Participants With Revascularization
時間枠：12 months
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Number of participants with any revascularization-Part of composite endpoint NACE
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12 months
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Number of Participants With Stent Thrombosis
時間枠：12 months
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Number of participants with Stent Thrombosis - Part of composite endpoint NACE
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12 months
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Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year
時間枠：3 year
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Number of participants with Composite primary endpoint MACCE (any first event) at 3 year
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3 year
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Number of Participants With All Cause Death at 3 Year
時間枠：3 year
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Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death
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3 year
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Number of Participants With Cardiac Death at 3 Year
時間枠：3 year
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Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death
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3 year
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Number of Participants With Spontaneous MI at 3 Year
時間枠：3 year
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Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI
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3 year
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Number of Participants With Peri-procedural MI at 3 Year
時間枠：3 year
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Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI
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3 year
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Number of Participants With Urgent Revascularization at 3 Year
時間枠：3 year
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Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation
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3 year
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Number of Participants With Elective Revascularization at 3 Year
時間枠：3 year
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Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation
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3 year
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Number of Participants With Cerebrovascular Event
時間枠：3 year
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Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event
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3 year
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Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year
時間枠：3 years
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Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 3 year (NACE i.e.
Net Adverse Clinical Events)
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3 years
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Number of Participants With Death From Any Cause or MI
時間枠：3 year
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Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 3 year
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3 year
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Number of Participants With Major Bleeding at 3 Year
時間枠：3 year
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Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year
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3 year
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Number of Participants With Hospitalization
時間枠：3 year
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Number of participants with Hospitalization for heart failure, unstable angina, MI
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3 year
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Number of Participants With Hospitalization at 3 Year
時間枠：3 year
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Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain
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3 year
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Number of Participants With Stent Thrombosis at 3 Year
時間枠：3 year
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Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE
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3 year
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Number of Participants With Any Bleeding at 3 Year
時間枠：3 year
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Number of participants with any bleeding at 3 year - Part of composite endpoint NACE
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3 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 |
|---|---|---|
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A Comparison of the Number of Patients in Both Groups With Treated Lesions With FFR ≤ 0.80 Versus Patients With Untreated Lesions With FFR ≤ 0.80;
時間枠：3 year
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FFR+/PCI+ vs FFR+/PCI- Comparison of patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days (groups A+C, n=202 patients) with patients having FFR positive lesions that did not undergo revascularization (group D, n=231 patients),
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3 year
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Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80
時間枠：3 year
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Comparison of acute versus staged PCI treatment for lesions with FFR
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3 year
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Comparison of PCI vs Medical Therapy in FFR Negative Lesions
時間枠：3 year
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comparison of patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results) and patients receiving medical therapy for FFR-negative lesions in the non-IRA
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3 year
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Peter Smits, MD. PHD、Maastadhospital / MCR
- スタディチェア：Elmir Omerovic, MD PhD、Sahlgrenska Hospital Götheborg
- スタディチェア：Gert Richardt, MD PhD、Herzzentrum Segeberger Kliniken
- スタディチェア：Franz-Josef Neumann, MD PhD、Herz-Zentrum Bad Krozingen
出版物と役立つリンク
一般刊行物
- Wang LJ, Han S, Zhang XH, Jin YZ. Fractional flow reserve-guided complete revascularization versus culprit-only revascularization in acute ST-segment elevation myocardial infarction and multi-vessel disease patients: a meta-analysis and systematic review. BMC Cardiovasc Disord. 2019 Mar 1;19(1):49. doi: 10.1186/s12872-019-1022-6.
- Piroth Z, Fulop G, Boxma-de Klerk BM, Abdelghani M, Omerovic E, Andreka P, Fontos G, Neumann FJ, Richardt G, Smits PC. Correlation and Relative Prognostic Value of Fractional Flow Reserve and Pd/Pa of Nonculprit Lesions in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010796. doi: 10.1161/CIRCINTERVENTIONS.121.010796. Epub 2022 Jan 20.
- Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.
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 (実際)
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。