Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
- Conditions
- Stable AnginaMultivessel Coronary Artery Disease
- Interventions
- Procedure: Percutaneous coronary intervention (PCI)Diagnostic Test: Symptom assessment during experimentally induced ischaemia
- Registration Number
- NCT06400290
- Lead Sponsor
- Imperial College London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
-
Eligibility for PCI due to angina
-
Anatomical evidence of significant multi-vessel coronary stenosis defined by either:
- ≥70% stenosis in two or more coronary arteries of ≥2.5mm visual diameter stenosis, on invasive coronary angiography (ICA)
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with stable angina Symptom assessment during experimentally induced ischaemia Patients who: 1. Are symptomatic with angina 2. Have anatomically severe multi-vessel coronary artery disease 3. Have physiological evidence of myocardial ischaemia Patients with stable angina Percutaneous coronary intervention (PCI) Patients who: 1. Are symptomatic with angina 2. Have anatomically severe multi-vessel coronary artery disease 3. Have physiological evidence of myocardial ischaemia
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Angina severity as assessed by Canadian Cardiovascular Society Class 57 days Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)
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)
Psychological impact of angina as assessed by the PHQ-9 questionnaire 57 days PHQ-9 Questionnaire (0-27), (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)
Change in angina symptom score 57 days Fractional Change in Angina Frequency (0-1) (Lower 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 Beck Depression Inventory 57 days Beck Depression Inventory (0-63), (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)
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)
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)
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 McGill Pain Questionnaire 57 days McGill Pain Questionnaire (Score 0-78), (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)
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)
Trial Locations
- Locations (6)
Essex Cardiothoracic Centre
🇬🇧Basildon, United Kingdom
Imperial College NHS Trust
🇬🇧London, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
St Georges University Hospital
🇬🇧London, United Kingdom
Portsmouth Hospitals University NHS Trust
🇬🇧Portsmouth, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom