Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Placebo-controlled similarity score during induced ischaemia at the coronary stenosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Inability to consent
结局指标
主要结局
Placebo-controlled similarity score during induced ischaemia at the coronary stenosis
时间窗: 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)
次要结局
- Angina severity as assessed by Canadian Cardiovascular Society Class(57 days)
- Angina symptom type during induced ischaemia at the coronary stenosis(Intra-procedural)
- Angina severity as assessed by MRC dyspnoea scale(57 days)
- Psychological impact of angina as assessed by the PHQ-9 questionnaire(57 days)
- Placebo-controlled intensity score during induced ischaemia at the coronary stenosis(Intra-procedural)
- Change in angina symptom score(57 days)
- Quality of Life assessed with the EQ-5D-5L questionnaire(57 days)
- Psychological impact of angina as assessed by the Beck Depression Inventory(57 days)
- Psychological impact of angina as assessed by the Coping Strategies Questionnaire(57 days)
- Psychological impact of angina as assessed by the Pain Catastrophizing Scale(57 days)
- Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire(57 days)
- Psychological impact of angina as assessed by the Profile of mood states questionnaire(57 days)
- Need for anti-anginal medication introduction and uptitration(57 days)
- Angina type as assessed by the McGill Pain Questionnaire(57 days)
- Psychological impact of angina as assessed by the SCL-90 Questionnaire(57 days)
- Angina type as assessed by the Rose Chest Pain Questionnaire(57 days)