Clinical trial NCT03082989: Evolving Routine Standards in Intracoronary Physiology
Official title: Prospective Study Evaluating the Routine Standard Use of Fractional Flow Reserve and Disagreement With Guideline Recommendations: a Nationwide Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Società Italiana di Cardiologia Invasiva
First posted: 2017-03-17
Enrollment: 1858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography

Brief summary: Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention.

Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

Detailed description: Fractional flow reserve (FFR) has been validated as a reliable surrogate for inducible ischemia, supporting its use during invasive procedures for functional assessment of coronary lesions. Landmark randomized trials have demonstrated that deferral of nonsignificant lesions based on FFR is not only safe, but also that FFR-guided revascularization is associated with a better clinical outcome up to 2 years, when compared with standard angiography.

In spite of the overwhelming evidence of its potential clinical and economic benefits and strong guideline recommendation, the adoption of FFR in the real-world is perceived to vary significantly. Reasons for this disparity are several, but most operators still do rely the most on angiographic eye-balling to decide on the functional significance of coronary lesions and the need for revascularization.

Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention.

Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

Eligibility criteria: Inclusion Criteria:

FRACTIONAL FLOW RESERVE PERFORMED GROUP

* age \>18 years
* written consent
* assessment with FFR of at least one coronary lesion

FRACTIONAL FLOW RESERVE NOT PERFORMED GROUP

* age \>18 years
* written consent
* absence of assessment with FFR of at least one coronary lesion

  + at least one of the following criteria
  1. stable coronary artery disease, absence of non-invasive stress test, evidence of coronary lesions between 50%-90% (visual estimation or quantitative coronary analysis)
  2. stable coronary artery disease, presence of non-invasive stress test, evidence of coronary lesions between 50%-70% (visual estimation or quantitative coronary analysis)
  3. acute coronary syndrome, culprit lesion not identifiable or coronary lesions different from the culprit between 50%-70% (visual estimation or quantitative coronary analysis)

     Exclusion Criteria:
* written consent denied

Primary outcomes:
measure: agreement with current guidelines
timeFrame: intra-procedure
Secondary outcomes:
measure: reasons leading to FFR disuse
timeFrame: intra-procedure
Other outcomes:
Locations:
city: Cona
country: Italy
facility: University Hospital of Ferrara
state: Ferrara
Study officials:
affiliation: Humanitas, Rozzano (MI)
name: Marco Luciano Rossi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Humanitas, Rozzano (MI)
name: Giulio Stefanino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Ferrara
name: Matteo Tebaldi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Ferrara
name: Gianluca Campo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Siena
name: Massimo Fineschi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Cuneo
name: Giuseppe Musumeci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tebaldi M, Biscaglia S, Fineschi M, Musumeci G, Marchese A, Leone AM, Rossi ML, Stefanini G, Maione A, Menozzi A, Tarantino F, Lodolini V, Gallo F, Barbato E, Tarantini G, Campo G. Evolving Routine Standards in Invasive Hemodynamic Assessment of Coronary Stenosis: The Nationwide Italian SICI-GISE Cross-Sectional ERIS Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1482-1491. doi: 10.1016/j.jcin.2018.04.037. Epub 2018 May 23.