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Completed

NCT Number: NCT01835808

Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CNCDC

Coimbra, Coimbra District, 3000-306, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fractional flow reserve (St. Jude Medical pressure-wire)

Device

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

Other names: Pressure-Wire (St. Jude Medical)

Primary outcomes

  1. Major adverse cardiac events

    Time frame: One Year

    Combined endpoint of major adverse cardiac events (cardiovascular mortality, myocardial infarction and coronary revascularization)

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: One Year

    Cardiovascular mortality at one year

  2. Myocardial infarction

    Time frame: One year

    Rate of Myocardial infarction at one year

  3. Coronary revascularization

    Time frame: One year

    Unplanned coronary revascularization at one year

Other outcomes

  1. Impact of FFR in the clinical decision

    Time frame: During the procedure

    Impact (change in the original strategy) of FFR in the clinical decision of interventional cardiologists

  2. Mismatch between non invasive imaging stress tests and FFR

    Time frame: During the procedure

    Mismatch between non invasive imaging stress tests and functional evaluation with FFR in a "real world" (not selected) setting

Sponsors and collaborators

Lead sponsor

Portuguese Society of Cardiology

Other

Collaborators

  • Abbott Medical Devices
  • Portuguese Association of Interventional Cardiology

Registry information

Official study title

Observational Study of the Evaluation of FFR in the Treatment of Coronary Artery Disease

Acronym: POST-IT

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 19, 2013
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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