Evolving Routine Standards in Intracoronary Physiology

NCT ID: NCT03082989

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1858 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2017-10-20

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.

Conditions

Myocardial Ischemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

fractional flow reserve performed

consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography where the operator decided to use fractional flow reserve to drive the revascularization

fractional flow reserve performed

Intervention Type: DEVICE

assessing fractional flow reserve to drive revascularization

fractional flow reserve not performed

consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography and satisfying prespecified criteria where the operator decided to not use fractional flow reserve to drive the revascularization

fractional flow reserve not performed

Intervention Type: OTHER

description of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization

Interventions

fractional flow reserve performed

assessing fractional flow reserve to drive revascularization

Intervention Type: DEVICE

fractional flow reserve not performed

description of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Società Italiana di Cardiologia Invasiva

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Campo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Luciano Rossi, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas, Rozzano (MI)

Giulio Stefanino, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas, Rozzano (MI)

Matteo Tebaldi, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Ferrara

Gianluca Campo, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Ferrara

Massimo Fineschi, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Siena

Giuseppe Musumeci, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Cuneo

Locations

University Hospital of Ferrara

Cona, Ferrara, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 29803695 (View on PubMed)

Other Identifiers

110109

Identifier Type: -

Identifier Source: org_study_id