Status:
UNKNOWN
Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Royal Free Hospital NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
Conditions:
Stable Angina
Eligibility:
All Genders
18+ years
Brief Summary
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 correlat...
Eligibility Criteria
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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 8 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05459051
Start Date
September 1 2022
End Date
April 8 2025
Last Update
March 6 2024
Active Locations (6)
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1
Mid and South Essex NHS Foundation Trust
Basildon, United Kingdom
2
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, United Kingdom
3
Imperial College NHS Trust
London, United Kingdom
4
Royal Free Hospital NHS Foundation Trust
London, United Kingdom