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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR302493 | Other Grant/Funding Number | National Institute for Health and Care Research |
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| Name | Class |
|---|---|
| Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | OTHER_GOV |
| Mid and South Essex NHS Foundation Trust | OTHER |
| Imperial College Healthcare NHS Trust | OTHER |
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ORBITA-MOON is a double-blinded, placebo-controlled experimental study that aims to understand how the different coronary artery stenoses contribute to overall clinical angina in patients with multi-vessel coronary artery disease. This study will investigate the symptoms conferred by each stenosis, induced by experimental ischaemia, for 60 patients with multi-vessel coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with stable angina | Experimental | Patients who:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention (PCI) | Procedure | Coronary artery stenting for stable angina |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-controlled similarity score during induced ischaemia at the coronary stenosis | The patient scores the similarity of the angina experienced during the experimental balloon inflation procedure against the angina experienced before the procedure between 0-10 (Higher Score = Most similar) | Intra-procedural |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-controlled intensity score during induced ischaemia at the coronary stenosis | The patient scores the severity of the angina experienced during the experimental balloon inflation procedure between 0-10 (Higher Score = More severe) | Intra-procedural |
| Angina symptom type during induced ischaemia at the coronary stenosis |
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Inclusion Criteria:
Eligibility for PCI due to angina
Anatomical evidence of significant multi-vessel coronary stenosis defined by either:
Physiological evidence of ischaemia with a positive test corresponding to the coronary arteries to be stented, on at least one of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shayna Chotai, MBBS MRCP | Contact | 02075945735 | s.chotai@imperial.ac.uk | |
| Rasha Al-Lamee, PhD MRCP | Contact | 02075945735 | r.al-lamee13@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Rasha Al-Lamee, PhD MRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essex Cardiothoracic Centre | Recruiting | Basildon | United Kingdom |
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| St George's Healthcare NHS Trust |
| OTHER |
| Royal Free Hospital NHS Foundation Trust | OTHER |
All participants will partake in the same research protocol.
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Participants and outcomes assessors will be briefly blinded during the experimental research procedure, during the placebo-controlled balloon inflations when they are asked to report their symptoms. Once the inflations have been completed, all patients will go on to have stents and the blinded part of the protocol will be over.
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| Symptom assessment during experimentally induced ischaemia | Diagnostic Test | Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis. |
|
The patient will list all symptoms experienced during the experimental balloon inflation procedure. |
| Intra-procedural |
| Change in angina symptom score | Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome) | 57 days |
| Angina severity as assessed by Canadian Cardiovascular Society Class | Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome) | 57 days |
| Angina severity as assessed by MRC dyspnoea scale | MRC dyspnoea score (1-5) (Lower Score = Better Outcome) | 57 days |
| Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire | Seattle Angina Questionnaire (0-100), (Higher Score = Better Outcome) | 57 days |
| Quality of Life assessed with the EQ-5D-5L questionnaire | EQ-5D-5L Questionnaire (-0.59 to 1), (Higher Score = Better Outcome) | 57 days |
| Psychological impact of angina as assessed by the PHQ-9 questionnaire | PHQ-9 Questionnaire (0-27), (Lower Score = Better Outcome) | 57 days |
| Psychological impact of angina as assessed by the Beck Depression Inventory | Beck Depression Inventory (0-63), (Lower Score = Better Outcome) | 57 days |
| Psychological impact of angina as assessed by the Coping Strategies Questionnaire | Coping Strategies Questionnaire (13-52), (Higher Score = Better Outcome) | 57 days |
| Psychological impact of angina as assessed by the Pain Catastrophizing Scale | Pain Catastrophizing Scale (0-52), (Lower Score = Better Outcome) | 57 days |
| Psychological impact of angina as assessed by the Profile of mood states questionnaire | Profile of mood states Questionnaire (0-44), (Lower Score = Better Outcome) | 57 days |
| Psychological impact of angina as assessed by the SCL-90 Questionnaire | SCL-90 Questionnaire (0-360), (Lower Score = Better Outcome) | 57 days |
| Need for anti-anginal medication introduction and uptitration | Has the patient required anti-anginal introduction and/or uptitration. (Score 0-1), (0 = no, 1 = yes) | 57 days |
| Angina type as assessed by the Rose Chest Pain Questionnaire | Rose Chest Pain Questionnaire (Score positive or negative), (Positive = pain suggestive of coronary heart disease, negative = pain not suggestive of coronary artery disease) | 57 days |
| Angina type as assessed by the McGill Pain Questionnaire | McGill Pain Questionnaire (Score 0-78), (Lower Score = Better Outcome) | 57 days |
| Royal Bournemouth Hospital | Recruiting | Bournemouth | United Kingdom |
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| Royal Sussex County Hospital | Recruiting | Brighton | BN2 5BE | United Kingdom |
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| Imperial College NHS Trust | Recruiting | London | United Kingdom |
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| Royal Free London NHS Foundation Trust | Recruiting | London | United Kingdom |
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| St Georges University Hospital | Recruiting | London | United Kingdom |
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| Nottingham City Hospital | Recruiting | Nottingham | NG5 1PB | United Kingdom |
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| Portsmouth Hospitals University NHS Trust | Not yet recruiting | Portsmouth | United Kingdom |
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| University Hospital Southampton | Recruiting | Southampton | SO16 6YD | United Kingdom |
|
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| 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 |
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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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