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NCT Number: NCT06400290

Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

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.

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Multivessel Coronary Artery Disease Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essex Cardiothoracic Centre, Basildon, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Coronary Intervention (PCI)

Procedure

Coronary artery stenting for stable angina

Symptom assessment during experimentally induced ischaemia

Diagnostic Test

Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.

Primary outcomes

  1. Placebo-controlled similarity score during induced ischaemia at the coronary stenosis

    Time frame: 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 outcomes

  1. Placebo-controlled intensity score during induced ischaemia at the coronary stenosis

    Time frame: Intra-procedural

    The patient scores the severity of the angina experienced during the experimental balloon inflation procedure between 0-10 (Higher Score = More severe)

  2. Angina symptom type during induced ischaemia at the coronary stenosis

    Time frame: Intra-procedural

    The patient will list all symptoms experienced during the experimental balloon inflation procedure.

  3. Change in angina symptom score

    Time frame: 57 days

    Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)

  4. Angina severity as assessed by Canadian Cardiovascular Society Class

    Time frame: 57 days

    Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)

  5. Angina severity as assessed by MRC dyspnoea scale

    Time frame: 57 days

    MRC dyspnoea score (1-5) (Lower Score = Better Outcome)

  6. Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire

    Time frame: 57 days

    Seattle Angina Questionnaire (0-100), (Higher Score = Better Outcome)

  7. Quality of Life assessed with the EQ-5D-5L questionnaire

    Time frame: 57 days

    EQ-5D-5L Questionnaire (-0.59 to 1), (Higher Score = Better Outcome)

  8. Psychological impact of angina as assessed by the PHQ-9 questionnaire

    Time frame: 57 days

    PHQ-9 Questionnaire (0-27), (Lower Score = Better Outcome)

  9. Psychological impact of angina as assessed by the Beck Depression Inventory

    Time frame: 57 days

    Beck Depression Inventory (0-63), (Lower Score = Better Outcome)

  10. Psychological impact of angina as assessed by the Coping Strategies Questionnaire

    Time frame: 57 days

    Coping Strategies Questionnaire (13-52), (Higher Score = Better Outcome)

  11. Psychological impact of angina as assessed by the Pain Catastrophizing Scale

    Time frame: 57 days

    Pain Catastrophizing Scale (0-52), (Lower Score = Better Outcome)

  12. Psychological impact of angina as assessed by the Profile of mood states questionnaire

    Time frame: 57 days

    Profile of mood states Questionnaire (0-44), (Lower Score = Better Outcome)

  13. Psychological impact of angina as assessed by the SCL-90 Questionnaire

    Time frame: 57 days

    SCL-90 Questionnaire (0-360), (Lower Score = Better Outcome)

  14. Need for anti-anginal medication introduction and uptitration

    Time frame: 57 days

    Has the patient required anti-anginal introduction and/or uptitration. (Score 0-1), (0 = no, 1 = yes)

  15. Angina type as assessed by the Rose Chest Pain Questionnaire

    Time frame: 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)

  16. Angina type as assessed by the McGill Pain Questionnaire

    Time frame: 57 days

    McGill Pain Questionnaire (Score 0-78), (Lower Score = Better Outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Rasha Al-Lamee, PhD MRCP

CONTACT

[email protected]

02075945735

Shayna Chotai, MBBS MRCP

CONTACT

[email protected]

02075945735

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Healthcare NHS Trust
  • Mid and South Essex NHS Foundation Trust
  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
  • Royal Free Hospital NHS Foundation Trust
  • St George's Healthcare NHS Trust

Registry information

Acronym: ORBITA-MOON

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 6, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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