Multivessel Coronary Artery Disease, Stable Angina
Conditions
Keywords
Angina, Multi-vessel coronary artery disease, Symptoms, Placebo-controlled symptom assessment
Brief summary
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.
Interventions
PROCEDUREPercutaneous coronary intervention (PCI)
Coronary artery stenting for stable angina
DIAGNOSTIC_TESTSymptom assessment during experimentally induced ischaemia
Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.
Sponsors
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
Imperial College Healthcare NHS Trust
St George's Healthcare NHS Trust
Royal Free Hospital NHS Foundation Trust
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
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
* Eligibility for PCI due to angina * Anatomical evidence of significant multi-vessel coronary stenosis defined by either: 1. ≥70% stenosis in two or more coronary arteries of ≥2.5mm visual diameter stenosis, on invasive coronary angiography (ICA) 2. Severe stenosis in ≥2 coronary arteries of ≥ 2.5mm visual diameter stenosis, on CTCA * Physiological evidence of ischaemia with a positive test corresponding to the coronary arteries to be stented, on at least one of the following: * dobutamine stress echocardiogram * cardiac MRI * myocardial perfusion study * invasive metrics of coronary physiology
Exclusion criteria
* Recent acute coronary syndrome * Previous coronary artery by-pass graft surgery (CABG) * Significant left main stem disease * Chronic total occlusion in the target artery(s) * Moderate to severe valvular disease * Moderate to severe left ventricular impairment * Contraindication to PCI or a drug-eluting stents * Contraindication to antiplatelet therapy * Contraindication to adenosine * Pregnant * Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placebo-controlled similarity score during induced ischaemia at the coronary stenosis | Intra-procedural | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in angina symptom score | 57 days | Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome) |
| Placebo-controlled intensity score during induced ischaemia at the coronary stenosis | Intra-procedural | The patient scores the severity of the angina experienced during the experimental balloon inflation procedure between 0-10 (Higher Score = More severe) |
| Angina symptom type during induced ischaemia at the coronary stenosis | Intra-procedural | The patient will list all symptoms experienced during the experimental balloon inflation procedure. |
| Angina severity as assessed by MRC dyspnoea scale | 57 days | MRC dyspnoea score (1-5) (Lower Score = Better Outcome) |
| Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire | 57 days | Seattle Angina Questionnaire (0-100), (Higher Score = Better Outcome) |
| Quality of Life assessed with the EQ-5D-5L questionnaire | 57 days | EQ-5D-5L Questionnaire (-0.59 to 1), (Higher Score = Better Outcome) |
| Psychological impact of angina as assessed by the PHQ-9 questionnaire | 57 days | PHQ-9 Questionnaire (0-27), (Lower Score = Better Outcome) |
| Angina severity as assessed by Canadian Cardiovascular Society Class | 57 days | Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome) |
| Psychological impact of angina as assessed by the Coping Strategies Questionnaire | 57 days | Coping Strategies Questionnaire (13-52), (Higher Score = Better Outcome) |
| Psychological impact of angina as assessed by the Pain Catastrophizing Scale | 57 days | Pain Catastrophizing Scale (0-52), (Lower Score = Better Outcome) |
| Psychological impact of angina as assessed by the Profile of mood states questionnaire | 57 days | Profile of mood states Questionnaire (0-44), (Lower Score = Better Outcome) |
| Psychological impact of angina as assessed by the SCL-90 Questionnaire | 57 days | SCL-90 Questionnaire (0-360), (Lower Score = Better Outcome) |
| Need for anti-anginal medication introduction and uptitration | 57 days | Has the patient required anti-anginal introduction and/or uptitration. (Score 0-1), (0 = no, 1 = yes) |
| Angina type as assessed by the Rose Chest Pain Questionnaire | 57 days | Rose Chest Pain Questionnaire (Score positive or negative), (Positive = pain suggestive of coronary heart disease, negative = pain not suggestive of coronary artery disease) |
| Angina type as assessed by the McGill Pain Questionnaire | 57 days | McGill Pain Questionnaire (Score 0-78), (Lower Score = Better Outcome) |
| Psychological impact of angina as assessed by the Beck Depression Inventory | 57 days | Beck Depression Inventory (0-63), (Lower Score = Better Outcome) |
Countries
United Kingdom
Contacts
Primary ContactShayna Chotai, MBBS MRCP
Backup ContactRasha Al-Lamee, PhD MRCP
Outcome results
None listed