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Recruiting NCT06400290

Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

No phase Interventional Stable Angina Multivessel Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous coronary intervention (PCI), Symptom assessment during experimentally induced ischaemia.
Who it may be relevant to
Registry conditions: Stable Angina, Multivessel Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Placebo-controlled similarity score during induced ischaemia at the coronary stenosis [Time frame: Intra-procedural]
Secondary outcome measures (12)
  • Placebo-controlled intensity score during induced ischaemia at the coronary stenosis [Time frame: Intra-procedural]
  • Angina symptom type during induced ischaemia at the coronary stenosis [Time frame: Intra-procedural]
  • Change in angina symptom score [Time frame: 57 days]
  • Angina severity as assessed by Canadian Cardiovascular Society Class [Time frame: 57 days]
  • Angina severity as assessed by MRC dyspnoea scale [Time frame: 57 days]
  • Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire [Time frame: 57 days]
  • Quality of Life assessed with the EQ-5D-5L questionnaire [Time frame: 57 days]
  • Psychological impact of angina as assessed by the PHQ-9 questionnaire [Time frame: 57 days]
  • Psychological impact of angina as assessed by the Beck Depression Inventory [Time frame: 57 days]
  • Psychological impact of angina as assessed by the Coping Strategies Questionnaire [Time frame: 57 days]
  • Psychological impact of angina as assessed by the Pain Catastrophizing Scale [Time frame: 57 days]
  • Psychological impact of angina as assessed by the Profile of mood states questionnaire [Time frame: 57 days]

Eligibility criteria

Inclusion criteria

  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United Kingdom · 9 centers
  • 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
  • … and 1 more center

Identifiers

NCT: NCT06400290 · 21HH7372 · NIHR302493

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗