- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01835808
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Coimbra, Portugal, 3000-306
- CNCDC
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
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)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Major adverse cardiac events
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cardiovascular mortality
Tidsramme: One Year
|
Cardiovascular mortality at one year
|
One Year
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Myocardial infarction
Tidsramme: 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
Tidsramme: One year
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Unplanned coronary revascularization at one year
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One year
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Impact of FFR in the clinical decision
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sergio B Baptista, MD, Hospital Fernando Fonseca, Amadora, Portugal
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- POST-IT
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