Stable AnginaORBITA-MOONNCT06400290
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
A study testing Percutaneous coronary intervention (PCI) and Symptom assessment during experimentally induced ischaemia in people with Stable Angina and Multivessel Coronary Artery Disease, run by Imperial College London at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Multivessel Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention (PCI) and Symptom assessment during experimentally induced ischaemia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 13 Jun 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- cardiac MRI
- myocardial perfusion study
- CT-FFR
- invasive metrics of coronary physiology
Who cannot join
- 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
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- Contraindication to PCI or a drug-eluting stents
- Contraindication to antiplatelet therapy
- Contraindication to adenosine
- Pregnant
- Inability to consent
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United Kingdom8 sites, 8 recruiting
- Recruiting
Essex Cardiothoracic Centre
Basildon
Thomas Keeble, thomas.keeble@btuh.nhs.uk
- Recruiting
Royal Bournemouth Hospital
Bournemouth
Peter O'Kane, peter.o'kane@uhd.nhs.uk
- Recruiting
Royal Sussex County Hospital
Brighton, BN2 5BE
David Hildick-Smith, +4401903205111, david.hildick-smith@nhs.net
- Recruiting
Imperial College NHS Trust
London
Shayna Chotai, 02075945735, s.chotai@imperial.ac.uk
Rasha Al-Lamee
- Recruiting
Royal Free London NHS Foundation Trust
London
Tushar Kotecha, tushar.kotecha@nhs.net
- Recruiting
St Georges University Hospital
London
Rupert Williams, rupertwilliams@nhs.net
- Not yet recruiting
Portsmouth Hospitals University NHS Trust
Portsmouth
Peter Haworth, peter.haworth@porthosp.nhs.uk
- Recruiting
University Hospital Southampton
Southampton, SO16 6YD
Nick Curzen, 023 8077 7222, nick.curzen@uhs.nhs.uk
About this study
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 50 patients with multi-vessel coronary artery disease.
- Conditions
- Stable Angina, Multivessel Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention (PCI), Symptom assessment during experimentally induced ischaemia
- Keywords
- Angina, Multi-vessel coronary artery disease, Symptoms, Placebo-controlled symptom assessment
- Medical subject headings
- Angina, Stable, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Procedure or surgery
Coronary artery stenting for stable angina
Symptom assessment during experimentally induced ischaemiaDiagnostic test
Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stable angina | Experimental | Patients who:
1. Are symptomatic with angina
2. Have anatomically severe multi-vessel coronary artery disease
3. Have physiological evidence of myocardial ischaemia Receives: Procedure: Percutaneous coronary intervention (PCI); Diagnostic Test: Symptom assessment during experimentally induced ischaemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-controlled similarity score during induced ischaemia at the coronary stenosis
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)
Measured: Intra-procedural
Secondary outcomes (16)
Placebo-controlled intensity score during induced ischaemia at the coronary stenosis
The patient scores the severity of the angina experienced during the experimental balloon inflation procedure between 0-10 (Higher Score = More severe)
Measured: Intra-procedural
Angina symptom type during induced ischaemia at the coronary stenosis
The patient will list all symptoms experienced during the experimental balloon inflation procedure.
Measured: Intra-procedural
Change in angina symptom score
Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)
Measured: 57 days
Angina severity as assessed by Canadian Cardiovascular Society Class
Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)
Measured: 57 days
Angina severity as assessed by MRC dyspnoea scale
MRC dyspnoea score (1-5) (Lower Score = Better Outcome)
Measured: 57 days
Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire
Seattle Angina Questionnaire (0-100), (Higher Score = Better Outcome)
Measured: 57 days
Quality of Life assessed with the EQ-5D-5L questionnaire
EQ-5D-5L Questionnaire (-0.59 to 1), (Higher Score = Better Outcome)
Measured: 57 days
Psychological impact of angina as assessed by the PHQ-9 questionnaire
PHQ-9 Questionnaire (0-27), (Lower Score = Better Outcome)
Measured: 57 days
Psychological impact of angina as assessed by the Beck Depression Inventory
Beck Depression Inventory (0-63), (Lower Score = Better Outcome)
Measured: 57 days
Psychological impact of angina as assessed by the Coping Strategies Questionnaire
Coping Strategies Questionnaire (13-52), (Higher Score = Better Outcome)
Measured: 57 days
Psychological impact of angina as assessed by the Pain Catastrophizing Scale
Pain Catastrophizing Scale (0-52), (Lower Score = Better Outcome)
Measured: 57 days
Psychological impact of angina as assessed by the Profile of mood states questionnaire
Profile of mood states Questionnaire (0-44), (Lower Score = Better Outcome)
Measured: 57 days
Psychological impact of angina as assessed by the SCL-90 Questionnaire
SCL-90 Questionnaire (0-360), (Lower Score = Better Outcome)
Measured: 57 days
Need for anti-anginal medication introduction and uptitration
Has the patient required anti-anginal introduction and/or uptitration. (Score 0-1), (0 = no, 1 = yes)
Measured: 57 days
Angina type as assessed by the Rose Chest Pain Questionnaire
Rose Chest Pain Questionnaire (Score positive or negative), (Positive = pain suggestive of coronary heart disease, negative = pain not suggestive of coronary artery disease)
Measured: 57 days
Angina type as assessed by the McGill Pain Questionnaire
McGill Pain Questionnaire (Score 0-78), (Lower Score = Better Outcome)
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start13 Jun 2024
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will partake in the same research protocol.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Rasha Al-Lamee, PhD MRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400290
- Sponsor's protocol ID
- 21HH7372
- Other IDs
- NIHR302493
- Acronym
- ORBITA-MOON
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
- ClinicalTrials.gov ID
- NCT06400290
- Acronym / sponsor ID
- ORBITA-MOON / 21HH7372
- Conditions
- Stable Angina, Multivessel Coronary Artery Disease
- Keywords
- Angina, Multi-vessel coronary artery disease, Symptoms, Placebo-controlled symptom assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Imperial College Healthcare NHS Trust
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 50 patients with multi-vessel coronary artery disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will partake in the same research protocol.
| Arm | Type | Receives |
|---|---|---|
| Patients with stable angina | Experimental | Procedure: Percutaneous coronary intervention (PCI), Diagnostic Test: Symptom assessment during experimentally induced ischaemiaPatients who: 1. Are symptomatic with angina 2. Have anatomically severe multi-vessel coronary artery disease 3. Have physiological evidence of myocardial ischaemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eligibility for PCI due to angina
- Anatomical evidence of significant multi-vessel coronary stenosis defined by either:
- Physiological evidence of ischaemia with a positive test corresponding to the coronary arteries to be stented, on at least one of the following:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention (PCI)Coronary artery stenting for stable angina | Procedure or surgery | Patients with stable angina |
| Symptom assessment during experimentally induced ischaemiaTransient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis. | Diagnostic test | Patients with stable angina |
Primary outcome
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)
16 secondary outcomes
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
Psychological impact of angina as assessed by the SCL-90 Questionnaire
Time frame: 57 days
Need for anti-anginal medication introduction and uptitration
Time frame: 57 days
Angina type as assessed by the Rose Chest Pain Questionnaire
Time frame: 57 days
Angina type as assessed by the McGill Pain Questionnaire
Time frame: 57 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rasha Al-Lamee, PhD MRCP principal investigator
Imperial College London
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (PCI) and Symptom assessment during experimentally induced ischaemia in people with Stable Angina and Multivessel Coronary Artery Disease, run by Imperial College London at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shayna Chotai, MBBS MRCP (02075945735, s.chotai@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-controlled similarity score during induced ischaemia at the coronary stenosis (time frame: Intra-procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.