NCT03082989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,858

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

March 13, 2017

Last Update Submit

May 1, 2018

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • agreement with current guidelines

    percentage of patients receiving a FFR assessment in agreement with current guidelines

    intra-procedure

Secondary Outcomes (1)

  • reasons leading to FFR disuse

    intra-procedure

Study Arms (2)

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

Device: fractional flow reserve performed

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

Other: fractional flow reserve not performed

Interventions

fractional flow reserve performedDEVICE

assessing fractional flow reserve to drive revascularization

fractional flow reserve performed
fractional flow reserve not performedOTHER

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

fractional flow reserve not performed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography

You may qualify if:

  • 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
  • stable coronary artery disease, absence of non-invasive stress test, evidence of coronary lesions between 50%-90% (visual estimation or quantitative coronary analysis)
  • stable coronary artery disease, presence of non-invasive stress test, evidence of coronary lesions between 50%-70% (visual estimation or quantitative coronary analysis)
  • acute coronary syndrome, culprit lesion not identifiable or coronary lesions different from the culprit between 50%-70% (visual estimation or quantitative coronary analysis)

You may not qualify if:

  • written consent denied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Related Publications (1)

  • 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.

    PMID: 29803695DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Marco Luciano Rossi, MD

    Humanitas, Rozzano (MI)

    PRINCIPAL INVESTIGATOR

  • Giulio Stefanino, MD

    Humanitas, Rozzano (MI)

    PRINCIPAL INVESTIGATOR

  • Matteo Tebaldi, MD

    AOU Ferrara

    PRINCIPAL INVESTIGATOR

  • Gianluca Campo, MD

    AOU Ferrara

    PRINCIPAL INVESTIGATOR

  • Massimo Fineschi, MD

    AOU Siena

    PRINCIPAL INVESTIGATOR

  • Giuseppe Musumeci, MD

    AOU Cuneo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 13, 2017

First Posted

March 17, 2017

Study Start

March 13, 2017

Primary Completion

September 30, 2017

Study Completion

October 20, 2017

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

IT(1)