Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

Обзор

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.

Вмешательства

• Процедура Percutaneous coronary intervention (PCI)
  Coronary artery stenting for stable angina
• Диагностический тест Symptom assessment during experimentally induced ischaemia
  Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.

Первичные конечные точки

• Placebo-controlled similarity score during induced ischaemia at the coronary stenosis [Срок оценки: Intra-procedural]

Вторичные конечные точки (12)

• Placebo-controlled intensity score during induced ischaemia at the coronary stenosis [Срок оценки: Intra-procedural]
• Angina symptom type during induced ischaemia at the coronary stenosis [Срок оценки: Intra-procedural]
• Change in angina symptom score [Срок оценки: 57 days]
• Angina severity as assessed by Canadian Cardiovascular Society Class [Срок оценки: 57 days]
• Angina severity as assessed by MRC dyspnoea scale [Срок оценки: 57 days]
• Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire [Срок оценки: 57 days]
• Quality of Life assessed with the EQ-5D-5L questionnaire [Срок оценки: 57 days]
• Psychological impact of angina as assessed by the PHQ-9 questionnaire [Срок оценки: 57 days]
• Psychological impact of angina as assessed by the Beck Depression Inventory [Срок оценки: 57 days]
• Psychological impact of angina as assessed by the Coping Strategies Questionnaire [Срок оценки: 57 days]
• Psychological impact of angina as assessed by the Pain Catastrophizing Scale [Срок оценки: 57 days]
• Psychological impact of angina as assessed by the Profile of mood states questionnaire [Срок оценки: 57 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Великобритания · 9 центров

• Essex Cardiothoracic Centre — Basildon
• Royal Bournemouth Hospital — Bournemouth
• Royal Sussex County Hospital — Brighton
• Imperial College NHS Trust — London
• Royal Free London NHS Foundation Trust — London
• St Georges University Hospital — London
• Nottingham City Hospital — Nottingham
• Portsmouth Hospitals University NHS Trust — Portsmouth
• … и ещё 1 центр

Идентификаторы

NCT: NCT06400290 · 21HH7372 · NIHR302493

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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