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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Portuguese Association of Interventional Cardiology
St. Jude Medical
Information provided by (Responsible Party):
Portuguese Society of Cardiology
ClinicalTrials.gov Identifier:
NCT01835808
First received: April 16, 2013
Last updated: June 19, 2014
Last verified: June 2014

April 16, 2013
June 19, 2014
March 2012
November 2014   (final data collection date for primary outcome measure)
Major adverse cardiac events [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
Combined endpoint of major adverse cardiac events (cardiovascular mortality, myocardial infarction and coronary revascularization)
Same as current
Complete list of historical versions of study NCT01835808 on ClinicalTrials.gov Archive Site
  • Cardiovascular mortality [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    Cardiovascular mortality at one year
  • Myocardial infarction [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Rate of Myocardial infarction at one year
  • Coronary revascularization [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Unplanned coronary revascularization at one year
Same as current
  • Impact of FFR in the clinical decision [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Impact (change in the original strategy) of FFR in the clinical decision of interventional cardiologists
  • Mismatch between non invasive imaging stress tests and FFR [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Mismatch between non invasive imaging stress tests and functional evaluation with FFR in a "real world" (not selected) setting
Same as current
 
Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease
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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Year
Not Provided
Non-Probability Sample

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

Coronary Artery Disease
Device: 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)
Other Name: Pressure-Wire (St. Jude Medical)
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).
Intervention: Device: Fractional flow reserve (St. Jude Medical pressure-wire)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1000
November 2014
November 2014   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01835808
POST-IT
Yes
Portuguese Society of Cardiology
Portuguese Society of Cardiology
  • Portuguese Association of Interventional Cardiology
  • St. Jude Medical
Principal Investigator: Sergio B Baptista, MD Hospital Fernando Fonseca, Amadora, Portugal
Portuguese Society of Cardiology
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP