Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

Not Applicable

Recruiting

• Conditions: Stable Angina; Multivessel Coronary Artery Disease

• 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

Study Timeline

• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-06
• Study Start: 2024-06-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06
• Primary Completion: 2027-01
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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 (9)

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

Nottingham City Hospital; 🇬🇧 Nottingham, United Kingdom

University Hospital Southampton; 🇬🇧 Southampton, United Kingdom

Essex Cardiothoracic Centre; 🇬🇧 Basildon, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Imperial College NHS Trust; 🇬🇧 London, United Kingdom

Royal Free London NHS Foundation Trust; 🇬🇧 London, United Kingdom

St Georges University Hospital; 🇬🇧 London, United Kingdom

Portsmouth Hospitals University NHS Trust; 🇬🇧 Portsmouth, United Kingdom