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| Name | Class |
|---|---|
| St George's University Hospitals NHS Foundation Trust | OTHER |
| Royal Free Hospital NHS Foundation Trust | OTHER |
| University Hospitals Dorset NHS Foundation Trust | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with stable coronary artery disease | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention (PCI) | Procedure | Clinically indicated PCI for the management of stable angina |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-individual difference in FFR and NHPR angina thresholds | 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. | Intra-procedural |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the angina threshold with other invasive physiological assessments | 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) | Intra-procedural |
| Correlation of the angina threshold with anatomical characteristics assessed with computed tomography coronary angiography (CTCA) |
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Inclusion Criteria:
Eligibility for PCI due to angina or angina-equivalent symptoms on exertion
2 severe epicardial stenoses in a major coronary artery, defined as:
Evidence of ischaemia on an invasive or non-invasive test, including:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla Chiew, MBBS MRCP | Contact | 020 7594 5735 | kayla.chiew@imperial.ac.uk | |
| Rasha Al-Lamee, MBBS PhD MRCP | Contact | 020 7594 5735 | r.al-lamee13@imperial.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid and South Essex NHS Foundation Trust | Recruiting | Basildon | United Kingdom |
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| Mid and South Essex NHS Foundation Trust |
| OTHER |
| Imperial College Healthcare NHS Trust | OTHER |
| Chelsea and Westminster NHS Foundation Trust | OTHER |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | OTHER |
All participants will partake in the same research protocol.
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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.
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| Measurement of the angina threshold | Diagnostic Test | 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. |
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Including proportion of myocardial mass subtended (%), coronary artery territory (LAD, LCx, RCA), and lesion location along a vessel (proximal, mid, distal) |
| 14 days |
| Correlation of the angina threshold with anatomical characteristics assessed with quantitative coronary angiography (QCA) | Including lesion length (mm), minimum lumen diameter, (mm) percent diameter stenosis (%), and reference vessel diameter (mm) | 14 days |
| Correlation of the angina threshold with anatomical characteristics assessed with intravascular imaging | 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) | Intra-procedural |
| Correlation of the angina threshold with features on a stress perfusion cardiac magnetic resonance imaging (CMR) scan | Including myocardial perfusion reserve (MPR), number of segments of infarcted myocardium, and percentage mural infarct depth (%) | 14 days |
| Correlation of the angina threshold with baseline symptoms, quality of life and pain perception | Assessed with the ORBITA-app and validated questionnaires (SAQ, EQ5D5L) | 14 days |
| University Hospitals Dorset NHS Foundation Trust | Not yet recruiting | Bournemouth | United Kingdom |
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| Chelsea and Westminster Hospital NHS Foundation Trust | Recruiting | London | United Kingdom |
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| Guy's and St Thomas' NHS Foundation Trust | Not yet recruiting | London | United Kingdom |
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| Imperial College Healthcare NHS Trust | Recruiting | London | United Kingdom |
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| Royal Free London NHS Foundation Trust | Not yet recruiting | London | United Kingdom |
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| St George's University Hospitals NHS Foundation Trust | Not yet recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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