Stable Angina
Conditions
Keywords
Symptoms, Angina, Physiology, Placebo
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.
Interventions
DIAGNOSTIC_TESTRest-angina physiological assessment
The degree of stenosis required to cause angina at rest will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
DIAGNOSTIC_TESTExercise-angina physiological assessment
The degree of stenosis required to cause angina during exercise will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
Sponsors
Royal Free Hospital NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
St George's University Hospitals NHS Foundation Trust
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Portsmouth Hospitals NHS Trust
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| The FFR difference between the rest and exercise states | Intra-procedural | Values 0.00-1.00 (Lower = More significant disease) |
| Angina symptom type at the angina threshold | Intra-procedural | The patient will list all symptoms experienced at the angina threshold |
| 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) |
| The NHPR difference between the rest and exercise states | Intra-procedural | Values 0.00-1.00 (Lower = More significant disease) |
Countries
United Kingdom
Contacts
Primary ContactFiyyaz Ahmed-Jushuf, MBBS MRCP
Backup ContactRasha Al-Lamee, PhD MRCP
Outcome results
None listed