Clinical trial NCT06400290: Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Official title: Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stable Angina
Multivessel Coronary Artery Disease
Keywords: Angina
Multi-vessel coronary artery disease
Symptoms
Placebo-controlled symptom assessment
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
name: Mid and South Essex NHS Foundation Trust
name: Imperial College Healthcare NHS Trust
name: St George's Healthcare NHS Trust
name: Royal Free Hospital NHS Foundation Trust
First posted: 2024-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will partake in the same research protocol.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Placebo-controlled similarity score during induced ischaemia at the coronary stenosis
timeFrame: Intra-procedural
Secondary outcomes:
measure: Placebo-controlled intensity score during induced ischaemia at the coronary stenosis
timeFrame: Intra-procedural
measure: Angina symptom type during induced ischaemia at the coronary stenosis
timeFrame: Intra-procedural
measure: Change in angina symptom score
timeFrame: 57 days
measure: Angina severity as assessed by Canadian Cardiovascular Society Class
timeFrame: 57 days
measure: Angina severity as assessed by MRC dyspnoea scale
timeFrame: 57 days
measure: Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire
timeFrame: 57 days
measure: Quality of Life assessed with the EQ-5D-5L questionnaire
timeFrame: 57 days
measure: Psychological impact of angina as assessed by the PHQ-9 questionnaire
timeFrame: 57 days
measure: Psychological impact of angina as assessed by the Beck Depression Inventory
timeFrame: 57 days
measure: Psychological impact of angina as assessed by the Coping Strategies Questionnaire
timeFrame: 57 days
measure: Psychological impact of angina as assessed by the Pain Catastrophizing Scale
timeFrame: 57 days
measure: Psychological impact of angina as assessed by the Profile of mood states questionnaire
timeFrame: 57 days
measure: Psychological impact of angina as assessed by the SCL-90 Questionnaire
timeFrame: 57 days
measure: Need for anti-anginal medication introduction and uptitration
timeFrame: 57 days
measure: Angina type as assessed by the Rose Chest Pain Questionnaire
timeFrame: 57 days
measure: Angina type as assessed by the McGill Pain Questionnaire
timeFrame: 57 days
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Essex Cardiothoracic Centre
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: London
country: United Kingdom
facility: Imperial College NHS Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: St Georges University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: Imperial College London
name: Rasha Al-Lamee, PhD MRCP
role: PRINCIPAL_INVESTIGATOR
References: