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Long-term Outcome of Deferred Lesion Based on FFR (HALE-BOPP)

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ClinicalTrials.gov Identifier: NCT03079739
Recruitment Status : Active, not recruiting
First Posted : March 14, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Gianluca Campo, University Hospital of Ferrara

Brief 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. 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.

Condition or disease Intervention/treatment
Myocardial Ischemia Diagnostic Test: fractional flow reserve

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 1305 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Prospective Assessment of Long-term Outcome of Deferred Coronary Lesions Based on FFR Evaluation
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : August 31, 2024

Group/Cohort Intervention/treatment
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
Diagnostic Test: fractional flow reserve
assessment with FFR in at least one coronary lesion




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. target vessel failure [ Time Frame: 3 years ]
    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. target vessel failure [ Time Frame: 5 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • written consent
  • age >18 years
  • FFR assessment in at least one coronary lesion

Exclusion Criteria:

  • life expectancy <1 year because of known noncardiovascular comorbidity
  • unwillingness to provide written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079739


Locations
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Italy
Clinica Montevergine SPA
Mercogliano, Avellino, Italy
University Hospital of Ferrara
Cona, Ferrara, Italy, 44124
Ospedale San Filippo e Nicola
Avezzano, L'Aquila, Italy
Clinica San Carlo
Paderno Dugnano, Milano, Italy
Istituto Clinico Sant'Anna
Brescia, Italy
Ospedale Valduce
Como, Italy
Clinica Sant'Ambrogio
Milano, Italy
Istituto Auxologico Italiano
Milano, Italy
AOU di Sassari
Sassari, Italy
Sponsors and Collaborators
University Hospital of Ferrara

Additional Information:

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Responsible Party: Gianluca Campo, Associate Professor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03079739     History of Changes
Other Study ID Numbers: 161082
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Ischemia
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases