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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings