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

22 maj 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

918

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Portugal
      • Coimbra, Portugal, 3000-306
        • CNCDC

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
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).
Enhet: Fractional flow reserve (St. Jude Medical pressure-wire)
CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation)
Andra namn:
  • Pressure-Wire (St. Jude Medical)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Major adverse cardiac events
Tidsram: One Year
Combined endpoint of major adverse cardiac events (cardiovascular mortality, myocardial infarction and coronary revascularization)
One Year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cardiovascular mortality
Tidsram: One Year
Cardiovascular mortality at one year
One Year
Myocardial infarction
Tidsram: One year
Rate of Myocardial infarction at one year
One year
Coronary revascularization
Tidsram: One year
Unplanned coronary revascularization at one year
One year

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Impact of FFR in the clinical decision
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Portuguese Society of Cardiology

Samarbetspartners

Abbott Medical Devices
Portuguese Association of Interventional Cardiology

Utredare

  • Huvudutredare: Sergio B Baptista, MD, Hospital Fernando Fonseca, Amadora, Portugal

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2012

Primärt slutförande (Faktisk)

1 november 2013

Avslutad studie (Faktisk)

1 november 2014

Studieregistreringsdatum

Först inskickad

16 april 2013

Först inskickad som uppfyllde QC-kriterierna

18 april 2013

Första postat (Uppskatta)

19 april 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 maj 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 maj 2015

Senast verifierad

1 maj 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • POST-IT

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