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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fractional flow reserve | Diagnostic Test | assessment with FFR in at least one coronary lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| target vessel failure |
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Inclusion Criteria:
Exclusion Criteria:
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all patients with established or suspected ischemic heart disease referred for coronary artery angiography in which at least 1 lesion is evaluated by FFR.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Montevergine SPA | Mercogliano | Avellino | Italy | |||
| Istituto Clinico Sant'Anna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39077421 | Derived | 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. |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D053805 | Fractional Flow Reserve, Myocardial |
| ID | Term |
|---|---|
| D003326 | Coronary Circulation |
| D001775 | Blood Circulation |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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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. |
| 5 years |
| Brescia |
| Brescia |
| Italy |
| Ospedale Valduce | Como | Como | Italy |
| University Hospital of Ferrara | Cona | Ferrara | 44124 | Italy |
| Clinica Sant'Ambrogio | Milan | Milano | Italy |
| Istituto Auxologico Italiano | Milan | Milano | Italy |
| Clinica San Carlo | Paderno Dugnano | Milano | Italy |
| AOU di Sassari | Sassari | Sassari | Italy |