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

Coronary Artery Disease Clinical Trial

— POST-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835808
• Other study ID #: POST-IT
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: May 22, 2015
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Portuguese Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 918
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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)

Locations

Country	Name	City	State
Portugal	CNCDC	Coimbra

Sponsors (3)

Lead Sponsor	Collaborator
Portuguese Society of Cardiology	Portuguese Association of Interventional Cardiology, St. Jude Medical

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of FFR in the clinical decision	Impact (change in the original strategy) of FFR in the clinical decision of interventional cardiologists	During the procedure	No
Other	Mismatch between non invasive imaging stress tests and FFR	Mismatch between non invasive imaging stress tests and functional evaluation with FFR in a "real world" (not selected) setting	During the procedure	No
Primary	Major adverse cardiac events	Combined endpoint of major adverse cardiac events (cardiovascular mortality, myocardial infarction and coronary revascularization)	One Year	Yes
Secondary	Cardiovascular mortality	Cardiovascular mortality at one year	One Year	Yes
Secondary	Myocardial infarction	Rate of Myocardial infarction at one year	One year	Yes
Secondary	Coronary revascularization	Unplanned coronary revascularization at one year	One year	Yes