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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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: Fractional flow reserve (St. Jude Medical pressure-wire)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Observational Study of the Evaluation of FFR in the Treatment of Coronary Artery Disease

Further study details as provided by Portuguese Society of Cardiology:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 1000
Study Start Date: March 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
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)

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835808

Locations
Portugal
CNCDC
Coimbra, Portugal, 3000-306
Sponsors and Collaborators
Portuguese Society of Cardiology
Portuguese Association of Interventional Cardiology
St. Jude Medical
Investigators
Principal Investigator: Sergio B Baptista, MD Hospital Fernando Fonseca, Amadora, Portugal
  More Information

No publications provided

Responsible Party: Portuguese Society of Cardiology
ClinicalTrials.gov Identifier: NCT01835808     History of Changes
Other Study ID Numbers: POST-IT
Study First Received: April 16, 2013
Last Updated: June 19, 2014
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Portuguese Society of Cardiology:
Fractional flow reserve

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014