Hale Bopp Study
Research type
Research Study
Full title
The prospective assessment of long-term outcome of deferred coronary lesions based on fractional flow reserve (HALE BOPP) study
IRAS ID
259623
Contact name
S Watkins
Contact email
Sponsor organisation
Azienda Ospedaliero Universitaria di Ferrara Cona
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 5 months, 31 days
Research summary
Treatment of myocardial ischemia with coronary intervention through the skin (PCI) in addition to optimal medical therapy reduces adverse events on the heart. However, less than half of the patients have non-invasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the significance of the blood circulation of a coronary lesion by measuring the pressures of the coronary and aortic vessels at the extremities during maximum blood flow. Previous studies have shown that FFR guidance revascularization improves clinical outcomes, quality of life and economic management. However, the reliability and safety of FFR assessment in different settings than stable coronary artery dysfunction are unclear. There are no data available from other clinically used devices. The HALE BOPP registry is a study that does not involve any particular medical intervention except the observation of what normally happens in normal medical practice initiated prospectively on all patients undergoing coronary angiography in which at least 1 lesion was evaluated by FFR.
REC name
West of Scotland REC 1
REC reference
19/WS/0046
Date of REC Opinion
14 May 2019
REC opinion
Further Information Favourable Opinion