Myocardial IschemiaERISNCT03082989
Evolving Routine Standards in Intracoronary Physiology
An observational study of Myocardial Ischemia, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- fractional flow reserve performed and fractional flow reserve not performed
- Type of treatment
- Medical device
- How many people
- 1,858 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2017to 20 Oct 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- written consent denied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating the Routine Standard Use of Fractional Flow Reserve and Disagreement With Guideline Recommendations: a Nationwide Study
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.
Read the 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
- Being tested
- fractional flow reserve performed, fractional flow reserve not performed
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional flow reserve performedDevice
assessing fractional flow reserve to drive revascularization
fractional flow reserve not performedOther
description of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: fractional flow reserve not performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement with current guidelines
percentage of patients receiving a FFR assessment in agreement with current guidelines
Measured: intra-procedure
Secondary outcomes (1)
reasons leading to FFR disuse
description of the main reasons leading operator to prefer not assessment of coronary
Measured: intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start13 Mar 2017
- Primary completion30 Sep 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,858 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana di Cardiologia Invasiva
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
- Investigators
- Marco Luciano Rossi, MD, Principal investigator, Humanitas, Rozzano (MI)Giulio Stefanino, MD, Principal investigator, Humanitas, Rozzano (MI)Matteo Tebaldi, MD, Principal investigator, AOU FerraraGianluca Campo, MD, Principal investigator, AOU FerraraMassimo Fineschi, MD, Principal investigator, AOU SienaGiuseppe Musumeci, MD, Principal investigator, AOU Cuneo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082989
- Sponsor's protocol ID
- 110109
- Acronym
- ERIS
- Status last verified
- May 2018
- First submitted
- 13 Mar 2017
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29803695
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Routine Standard Use of Fractional Flow Reserve and Disagreement With Guideline Recommendations: a Nationwide Study
- ClinicalTrials.gov ID
- NCT03082989
- Acronym / sponsor ID
- ERIS / 110109
- Conditions
- Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,858 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Società Italiana di Cardiologia Invasiva
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fractional flow reserve performed | – | Device: fractional flow reserve performedconsecutive 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 not performed | – | Other: fractional flow reserve not performedconsecutive 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- written consent denied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractional flow reserve performedassessing fractional flow reserve to drive revascularization | Device | fractional flow reserve performed |
| fractional flow reserve not performeddescription of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization | Other | fractional flow reserve not performed |
Primary outcome
agreement with current guidelines
Time frame: intra-procedure
percentage of patients receiving a FFR assessment in agreement with current guidelines
1 secondary outcome
reasons leading to FFR disuse
Time frame: intra-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 29803695Tebaldi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Luciano Rossi, MD principal investigator
Humanitas, Rozzano (MI)
Giulio Stefanino, MD principal investigator
Humanitas, Rozzano (MI)
Matteo Tebaldi, MD principal investigator
AOU Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
agreement with current guidelines (time frame: intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.