Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
- Conditions
- Stable Angina
- Interventions
- Diagnostic Test: Rest-angina physiological assessmentDiagnostic Test: Exercise-angina physiological assessment
- Registration Number
- NCT05459051
- Lead Sponsor
- Imperial College London
- 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 correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with stable angina Exercise-angina physiological assessment * Symptomatic * Anatomically severe single-vessel coronary artery disease * Physiological evidence of myocardial ischaemia Patients with stable angina Rest-angina physiological assessment * Symptomatic * Anatomically severe single-vessel coronary artery disease * Physiological evidence of myocardial ischaemia
- Primary Outcome Measures
Name Time Method The FFR and NHPR value at which the patient experiences angina in a rest state Intra-procedural Values 0.00-1.00 (Lower = More significant disease)
The FFR and NHPR value at which the patient experiences angina in an exercise state Intra-procedural Values 0.00-1.00 (Lower = More significant disease)
- Secondary Outcome Measures
Name Time Method The FFR difference between the rest and exercise states Intra-procedural Values 0.00-1.00 (Lower = More significant disease)
The NHPR difference between the rest and exercise states Intra-procedural Values 0.00-1.00 (Lower = More significant disease)
Angina severity score at the angina threshold Intra-procedural The patient scores the severity of the angina experienced during the procedure between 0-10 (Higher = More severe)
Angina similarity score at the angina threshold Intra-procedural The patient scores the similarity of the angina experienced during the procedure against the angina experienced before the procedure between 0-10 (Higher = Most similar)
Angina symptom type at the angina threshold Intra-procedural The patient will list all symptoms experienced at the angina threshold
Trial Locations
- Locations (6)
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom
St George's University Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
🇬🇧Bournemouth, United Kingdom
Mid and South Essex NHS Foundation Trust
🇬🇧Basildon, United Kingdom
Imperial College NHS Trust
🇬🇧London, United Kingdom
Royal Free Hospital NHS Foundation Trust
🇬🇧London, United Kingdom