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

NCT01835808 | Completed DMC

• 1 other identifier: POST-IT
• Study Type: observational
• Target: 918
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events

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

  One Year

Secondary Outcomes (3)

• Cardiovascular mortality

  One Year

• Myocardial infarction

  One year

• Coronary revascularization

  One year

Other Outcomes (2)

• Impact of FFR in the clinical decision

  During the procedure

• Mismatch between non invasive imaging stress tests and FFR

  During the procedure

Study Arms (1)

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)

Interventions

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)

Also known as: Pressure-Wire (St. Jude Medical)

Fractional Flow Reserve

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Patient not willing to participate (informed consent not signed).
• Life expectancy lower than 12 months (due to cardiac or non-cardiac disease)

Sponsors & Collaborators

• Portuguese Society of Cardiology: lead
• Portuguese Association of Interventional Cardiology: collaborator
• Abbott Medical Devices: collaborator

Study Sites (1)

CNCDC

Coimbra, Coimbra District, 3000-306, Portugal

Location

Related Publications (1)

• Baptista SB, Raposo L, Santos L, Ramos R, Cale R, Jorge E, Machado C, Costa M, Infante de Oliveira E, Costa J, Pipa J, Fonseca N, Guardado J, Silva B, Sousa MJ, Silva JC, Rodrigues A, Seca L, Fernandes R. Impact of Routine Fractional Flow Reserve Evaluation During Coronary Angiography on Management Strategy and Clinical Outcome: One-Year Results of the POST-IT. Circ Cardiovasc Interv. 2016 Jul;9(7):e003288. doi: 10.1161/CIRCINTERVENTIONS.115.003288.

  PMID: 27412867 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Sergio B Baptista, MD

  Hospital Fernando Fonseca, Amadora, Portugal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 19, 2013
• Study Start: March 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

PT (1)