Myocardial IschemiaHALE-BOPPNCT03079739
Long-term Outcome of Deferred Lesion Based on FFR
An observational study of Myocardial Ischemia, run by University Hospital of Ferrara at 8 sites in Italy.
Trial summary
Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. 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
- How many people
- 1,305 participants
- Where
- 8 sitesItaly
- Study dates
- 1 Mar 2017to 3 Aug 2022
- How long will I take part?
- 5 Years
- 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: all patients with established or suspected ischemic heart disease referred for coronary artery angiography in which at least 1 lesion is evaluated by FFR.
Who may be able to join
- written consent
- age >18 years
- FFR assessment in at least one coronary lesion
Who cannot join
- life expectancy <1 year because of known noncardiovascular comorbidity
- unwillingness to provide written informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Istituto Clinico Sant'Anna
Brescia, Brescia
Ospedale Valduce
Como, Como
University Hospital of Ferrara
Cona, Ferrara, 44124
Clinica Montevergine SPA
Mercogliano, Avellino
Clinica Sant'Ambrogio
Milan, Milano
Istituto Auxologico Italiano
Milan, Milano
Clinica San Carlo
Paderno Dugnano, Milano
AOU di Sassari
Sassari, Sassari
About this study
Official title: The Prospective Assessment of Long-term Outcome of Deferred Coronary Lesions Based on FFR Evaluation
Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices. The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.
Read the detailed description
Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices.
The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.
All centers capable of performing FFR were invited to participate and there were no predefined exclusion criteria, other than the patient's unwillingness to provide written informed consent.
The decision to perform FFR was left to the operator in each case. The study primary purpose was to evaluate, in the routine daily practice, the long-term clinical outcome of coronary lesions where the treatment was deferred based on FFR result.
An independent corelab will review all angiograms to perform quantitative coronary analysis, calculation of syntax score, residual syntax score, functional syntax score and, in ACS patients, discrimination between culprit and non culprit lesions An indipendent committee will assess and adjudicate all adverse events.
- Conditions
- Myocardial Ischemia
- Being tested
- fractional flow reserve
- 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 reserveDiagnostic test
assessment with FFR in at least one coronary lesion
| Study group | Role | What they receive |
|---|---|---|
| fractional flow reserve group | consecutive patients undergoing coronary artery angiography for established or suspected ischemic heart disease and receiving in at least one lesion FFR assessment Receives: Diagnostic Test: fractional flow reserve |
What is being measured
The primary outcome is the main question the study is designed to answer.
target vessel failure
cumulative occurrence of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. The vessel is defined target if it was that where fractional flow reserve is performed.
Measured: 1 year
Secondary outcomes (2)
target vessel failure
cumulative occurrence of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. The vessel is defined target if it was that where fractional flow reserve is performed.
Measured: 3 years
target vessel failure
cumulative occurrence of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. The vessel is defined target if it was that where fractional flow reserve is performed.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 Mar 2017
- Primary completion30 Mar 2021
- Study completion3 Aug 2022
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
- 1,305 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079739
- Sponsor's protocol ID
- 161082
- Acronym
- HALE-BOPP
- Status last verified
- Sep 2022
- First submitted
- 8 Mar 2017
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tebaldi M, Gallo F, Scoccia A, Durante A, Tedeschi D, Verdoliva S, Cortese B, Bilotta F, Watkins S, Ielasi A, Valentini G, Pavasini R, Serenelli M, D'Aniello E, Arena M, Pompei G, Scala A, Scollo E, Gibiino F, Caglioni S, Mele D, Marrone A, Biscaglia S, Barbato E, Campo G. Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study. Rev Cardiovasc Med. 2023 Feb 14;24(2):62. doi: 10.31083/j.rcm2402062. eCollection 2023 Feb.
PubMed 39077421
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Assessment of Long-term Outcome of Deferred Coronary Lesions Based on FFR Evaluation
- ClinicalTrials.gov ID
- NCT03079739
- Acronym / sponsor ID
- HALE-BOPP / 161082
- Conditions
- Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,305 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 14 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.
Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices. The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.
Detailed description
Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices.
The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.
All centers capable of performing FFR were invited to participate and there were no predefined exclusion criteria, other than the patient's unwillingness to provide written informed consent.
The decision to perform FFR was left to the operator in each case. The study primary purpose was to evaluate, in the routine daily practice, the long-term clinical outcome of coronary lesions where the treatment was deferred based on FFR result.
An independent corelab will review all angiograms to perform quantitative coronary analysis, calculation of syntax score, residual syntax score, functional syntax score and, in ACS patients, discrimination between culprit and non culprit lesions An indipendent committee will assess and adjudicate all adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fractional flow reserve group | – | Diagnostic Test: fractional flow reserveconsecutive patients undergoing coronary artery angiography for established or suspected ischemic heart disease and receiving in at least one lesion FFR assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with established or suspected ischemic heart disease referred for coronary artery angiography in which at least 1 lesion is evaluated by FFR.
Key inclusion criteria (3 listed)
- written consent
- age >18 years
- FFR assessment in at least one coronary lesion
Key exclusion criteria (2 listed)
- life expectancy <1 year because of known noncardiovascular comorbidity
- unwillingness to provide written informed consent
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 reserveassessment with FFR in at least one coronary lesion | Diagnostic test | fractional flow reserve group |
Primary outcome
target vessel failure
Time frame: 1 year
cumulative occurrence of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. The vessel is defined target if it was that where fractional flow reserve is performed.
2 secondary outcomes
target vessel failure
Time frame: 3 years
target vessel failure
Time frame: 5 years
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 27 Mar 2025.
- Derived from this study: PubMed 39077421Tebaldi M, Gallo F, Scoccia A, Durante A, Tedeschi D, Verdoliva S, Cortese B, Bilotta F, Watkins S, Ielasi A, Valentini G, Pavasini R, Serenelli M, D'Aniello E, Arena M, Pompei G, Scala A, Scollo E, Gibiino F, Caglioni S, Mele D, Marrone A, Biscaglia S, Barbato E, Campo G. Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study. Rev Cardiovasc Med. 2023 Feb 14;24(2):62. doi: 10.31083/j.rcm2402062. eCollection 2023 Feb.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites 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 8 sites 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 3 inclusion and 2 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 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
target vessel failure (time frame: 1 year). 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 NCT03079739, 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 27 Mar 2025.