Angina (Stable), Coronary Artery Disease(CAD), Ischaemic Heart Disease (IHD)
Conditions
Keywords
Angina, Coronary physiology, Coronary haemodynamics, Placebo-control, Symptoms
Brief summary
ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Sixty patients with symptoms of stable angina and 2 coronary artery stenoses amenable to percutaneous coronary intervention (PCI) will be recruited. This study will use intra-coronary balloon inflation during supine exercise on an ergometer to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that relates to angina onset, in real time, at the location of each stenosis.
Interventions
PROCEDUREPercutaneous coronary intervention (PCI)
Clinically indicated PCI for the management of stable angina
DIAGNOSTIC_TESTMeasurement of the angina threshold
Following stenting, the order in which to perform the angina threshold assessment at the location of each stent will be randomised. A non-compliant balloon with gradually be inflated over a pressure wire within the deployed stent to re-introduce stenosis. Simultaneously, the participant will exercise on a supine ergometer. At the point when angina is reproduced, the patient will rest and further balloon inflation will stop. Physiological measurements using the pressure wire will be taken with the inflated balloon in situ. This will represent the invasive physiological angina threshold. The balloon will then be deflated and removed. These steps will be repeated at the location of the second stent.
Sponsors
Imperial College London
St George's University Hospitals NHS Foundation Trust
Royal Free Hospital NHS Foundation Trust
University Hospitals Dorset NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
Imperial College Healthcare NHS Trust
Chelsea and Westminster NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
During cardiac catheterisation, there will be one blinded component to verify the reproducibility of symptoms against placebo. One true and one placebo balloon inflation will be performed, in a randomised order. Both the participant and outcome assessor will be blinded to the order of true or placebo balloon inflation. The participant will be asked to report any symptoms they have.
Intervention model description
All participants will partake in the same research protocol.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eligibility for PCI due to angina or angina-equivalent symptoms on exertion 2. 2 severe epicardial stenoses in a major coronary artery, defined as: 1. ≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA) 2. Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA 3. Evidence of ischaemia on an invasive or non-invasive test, including: 1. Physiological test during invasive coronary angiography (ICA) 2. Dobutamine stress echocardiography (DSE) 3. Stress perfusion cardiac magnetic resonance (CMR) 4. Myocardial perfusion scintigraphy (MPS) 5. Fractional flow reserve computed-tomography (FFR-CT)
Exclusion criteria
1. Age \<18 years 2. Acute coronary syndrome within 3 months 3. Previous coronary artery bypass graft 4. Significant left main stem disease 5. Single lesion amenable to PCI 6. Chronic total occlusion of the target artery 7. Moderate to severe valve disease 8. LVEF ≤40%, contraindication to PCI or drug-eluting stents 9. PCI performed with drug-eluting balloons without stenting 10. Contraindication to antiplatelet therapy 11. Contraindication to adenosine 12. Physical inability to exercise with an ergometer 13. Femoral artery access 14. Pregnancy 15. Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-individual difference in FFR and NHPR angina thresholds | Intra-procedural | Difference in invasively measured physiological angina thresholds at the site of the 2 stents within each participant, stratified by vascular territory and lesion location along a vessel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the angina threshold with other invasive physiological assessments | Intra-procedural | Including coronary artery disease pattern (focal, diffuse or mixed), presence of microvascular disease (IMR and CFR), extent of collateral flow (CFI), and pre- and post-PCI ischaemia (FFR and RFR) |
| Correlation of the angina threshold with anatomical characteristics assessed with computed tomography coronary angiography (CTCA) | 14 days | Including proportion of myocardial mass subtended (%), coronary artery territory (LAD, LCx, RCA), and lesion location along a vessel (proximal, mid, distal) |
| Correlation of the angina threshold with anatomical characteristics assessed with quantitative coronary angiography (QCA) | 14 days | Including lesion length (mm), minimum lumen diameter, (mm) percent diameter stenosis (%), and reference vessel diameter (mm) |
| Correlation of the angina threshold with anatomical characteristics assessed with intravascular imaging | Intra-procedural | Including lesion length (mm), pre-PCI minimum lumen area (mm2), post-PCI minimum stent area (mm2), reference vessel cross-sectional area (mm2), plaque characteristics (lipid, fibrotic, calcific) |
| Correlation of the angina threshold with features on a stress perfusion cardiac magnetic resonance imaging (CMR) scan | 14 days | Including myocardial perfusion reserve (MPR), number of segments of infarcted myocardium, and percentage mural infarct depth (%) |
| Correlation of the angina threshold with baseline symptoms, quality of life and pain perception | 14 days | Assessed with the ORBITA-app and validated questionnaires (SAQ, EQ5D5L) |
Countries
United Kingdom
Contacts
CONTACTKayla Chiew, MBBS MRCP
CONTACTRasha Al-Lamee, MBBS PhD MRCP
Outcome results
None listed