Overview
ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.
Eligibility
Inclusion Criteria:
- Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion
- Anatomical evidence of significant single-vessel coronary stenosis defined by either:
- ≥70% stenosis on invasive coronary angiography (ICA)
- Severe stenosis on CT coronary angiography (CTCA)
- Physiological evidence of ischaemia with a positive test on at least one of the
- following
-
- Stress echocardiography
- Cardiac magnetic resonance perfusion
- Myocardial perfusion scintigraphy
- Invasive metrics of coronary physiology
Exclusion Criteria:
- Age <18 years
- Recent acute coronary syndrome
- Previous coronary artery by-pass graft
- Significant left main stem disease
- Multivessel disease (defined as >50% angiographic stenosis in other vessels)
- Chronic total occlusion in the target artery
- Moderate to severe valvular disease
- Moderate to severe left ventricular impairment
- Chronotropic incompetence with a pacemaker
- Contraindication to PCI or a drug-eluting stents
- Contraindication to antiplatelet therapy
- Contraindication to adenosine
- Moderate to severe respiratory disease
- Physical inability to exercise
- Pregnant
- Inability to consent