Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina (ORBITA-MOON)

June 5, 2025 updated by: Imperial College London
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Basildon, United Kingdom
      • Bournemouth, United Kingdom
      • Brighton, United Kingdom, BN2 5BE
      • London, United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College NHS Trust
        • Contact:
        • Principal Investigator:
          • Rasha Al-Lamee
      • London, United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital
        • Contact:
      • Portsmouth, United Kingdom
      • Southampton, United Kingdom, so16 6yd
        • Recruiting
        • University Hospital Southampton
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with stable angina

Patients who:

  1. Are symptomatic with angina
  2. Have anatomically severe multi-vessel coronary artery disease
  3. Have physiological evidence of myocardial ischaemia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Intra-procedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Intra-procedural
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.
Intra-procedural
Change in angina symptom score
Time Frame: 57 days
Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)
57 days
Angina severity as assessed by Canadian Cardiovascular Society Class
Time Frame: 57 days
Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)
57 days
Angina severity as assessed by MRC dyspnoea scale
Time Frame: 57 days
MRC dyspnoea score (1-5) (Lower Score = Better Outcome)
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
Seattle Angina Questionnaire (0-100), (Higher Score = Better Outcome)
57 days
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)
57 days
Psychological impact of angina as assessed by the PHQ-9 questionnaire
Time Frame: 57 days
PHQ-9 Questionnaire (0-27), (Lower Score = Better Outcome)
57 days
Psychological impact of angina as assessed by the Beck Depression Inventory
Time Frame: 57 days
Beck Depression Inventory (0-63), (Lower Score = Better Outcome)
57 days
Psychological impact of angina as assessed by the Coping Strategies Questionnaire
Time Frame: 57 days
Coping Strategies Questionnaire (13-52), (Higher Score = Better Outcome)
57 days
Psychological impact of angina as assessed by the Pain Catastrophizing Scale
Time Frame: 57 days
Pain Catastrophizing Scale (0-52), (Lower Score = Better Outcome)
57 days
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)
57 days
Psychological impact of angina as assessed by the SCL-90 Questionnaire
Time Frame: 57 days
SCL-90 Questionnaire (0-360), (Lower Score = Better Outcome)
57 days
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)
57 days
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)
57 days
Angina type as assessed by the McGill Pain Questionnaire
Time Frame: 57 days
McGill Pain Questionnaire (Score 0-78), (Lower Score = Better Outcome)
57 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

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

Investigators

  • Principal Investigator: Rasha Al-Lamee, PhD MRCP, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21HH7372
  • NIHR302493 (Other Grant/Funding Number: National Institute for Health and Care Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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