Stable AnginaORBITA-FIRENCT05459051
Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
An observational study of Stable Angina, run by Imperial College London at 6 sites in United Kingdom.
Trial summary
ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina
- What is being tested?
- Rest-angina physiological assessment and Exercise-angina physiological assessment
- How many people
- 58 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 1 Sep 2022to 8 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patient with stable angina
Who may be able to join
- Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion
- Anatomical evidence of significant single-vessel coronary stenosis defined by either:
- ≥70% stenosis on invasive coronary angiography (ICA)
- Severe stenosis on CT coronary angiography (CTCA)
- Physiological evidence of ischaemia with a positive test on at least one of the following:
- Stress echocardiography
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- Cardiac magnetic resonance perfusion
- Myocardial perfusion scintigraphy
- Invasive metrics of coronary physiology
Who cannot join
- Age <18 years
- Recent acute coronary syndrome
- Previous coronary artery by-pass graft
- Significant left main stem disease
- Multivessel disease (defined as >50% angiographic stenosis in other vessels)
- Chronic total occlusion in the target artery
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- Moderate to severe valvular disease
- Moderate to severe left ventricular impairment
- Chronotropic incompetence with a pacemaker
- Contraindication to PCI or a drug-eluting stents
- Contraindication to antiplatelet therapy
- Contraindication to adenosine
- Moderate to severe respiratory disease
- Physical inability to exercise
- Pregnant
- Inability to consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
Mid and South Essex NHS Foundation Trust
Basildon
Thomas Keeble, thomas.keeble@btuh.nhs.uk
- Recruiting
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth
Peter O'Kane, peter.o'kane@rbch.nhs.uk
- Recruiting
Imperial College NHS Trust
London
Fiyyaz Ahmed-Jushuf, fiyyaz.ahmed-jushuf09@imperial.ac.uk
- Recruiting
Royal Free Hospital NHS Foundation Trust
London
Tushar Kotecha, tushar.kotecha@nhs.net
- Recruiting
St George's University Hospitals NHS Foundation Trust
London
James Spratt, james.spratt@nhs.net
- Recruiting
Portsmouth Hospitals NHS Trust
Portsmouth
Peter Haworth, peter.haworth@porthosp.nhs.uk
About this study
ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.
- Conditions
- Stable Angina
- Being tested
- Rest-angina physiological assessment, Exercise-angina physiological assessment
- Keywords
- Symptoms, Angina, Physiology, Placebo
- 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.
Rest-angina physiological assessmentDiagnostic test
The degree of stenosis required to cause angina at rest will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
Exercise-angina physiological assessmentDiagnostic test
The degree of stenosis required to cause angina during exercise will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stable angina | * Symptomatic
* Anatomically severe single-vessel coronary artery disease
* Physiological evidence of myocardial ischaemia Receives: Diagnostic Test: Rest-angina physiological assessment; Diagnostic Test: Exercise-angina physiological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The FFR and NHPR value at which the patient experiences angina in a rest state
Values 0.00-1.00 (Lower = More significant disease)
Measured: Intra-procedural
The FFR and NHPR value at which the patient experiences angina in an exercise state
Values 0.00-1.00 (Lower = More significant disease)
Measured: Intra-procedural
Secondary outcomes (5)
The FFR difference between the rest and exercise states
Values 0.00-1.00 (Lower = More significant disease)
Measured: Intra-procedural
The NHPR difference between the rest and exercise states
Values 0.00-1.00 (Lower = More significant disease)
Measured: Intra-procedural
Angina severity score at the angina threshold
The patient scores the severity of the angina experienced during the procedure between 0-10 (Higher = More severe)
Measured: Intra-procedural
Angina similarity score at the angina threshold
The patient scores the similarity of the angina experienced during the procedure against the angina experienced before the procedure between 0-10 (Higher = Most similar)
Measured: Intra-procedural
Angina symptom type at the angina threshold
The patient will list all symptoms experienced at the angina threshold
Measured: Intra-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Sep 2022
- Primary completion8 Apr 2025 (estimated)
- Study completion8 Apr 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Portsmouth Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Rasha Al-Lamee, PhD MRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459051
- Sponsor's protocol ID
- P91528
- Other IDs
- 22HH7546
- Acronym
- ORBITA-FIRE
- Status last verified
- Mar 2024
- First submitted
- 7 Jul 2022
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
- ClinicalTrials.gov ID
- NCT05459051
- Acronym / sponsor ID
- ORBITA-FIRE / P91528
- Conditions
- Stable Angina
- Keywords
- Symptoms, Angina, Physiology, Placebo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Portsmouth Hospitals NHS Trust
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 8 Apr 2025 (estimated)
- Study completion
- 8 Apr 2025 (estimated)
- First posted
- 14 Jul 2022 (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-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stable angina | – | Diagnostic Test: Rest-angina physiological assessment, Diagnostic Test: Exercise-angina physiological assessment* Symptomatic * Anatomically severe single-vessel coronary artery disease * Physiological evidence of myocardial ischaemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with stable angina
Key inclusion criteria (9 listed)
- Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion
- Anatomical evidence of significant single-vessel coronary stenosis defined by either:
- Physiological evidence of ischaemia with a positive test on at least one of the following:
Key exclusion criteria (16 listed)
- Age <18 years
- Recent acute coronary syndrome
- Previous coronary artery by-pass graft
- Significant left main stem disease
- Multivessel disease (defined as >50% angiographic stenosis in other vessels)
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 |
|---|---|---|
| Rest-angina physiological assessmentThe degree of stenosis required to cause angina at rest will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR. | Diagnostic test | Patients with stable angina |
| Exercise-angina physiological assessmentThe degree of stenosis required to cause angina during exercise will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR. | Diagnostic test | Patients with stable angina |
Primary outcome
The FFR and NHPR value at which the patient experiences angina in a rest state
Time frame: Intra-procedural
Values 0.00-1.00 (Lower = More significant disease)
The FFR and NHPR value at which the patient experiences angina in an exercise state
Time frame: Intra-procedural
Values 0.00-1.00 (Lower = More significant disease)
5 secondary outcomes
The FFR difference between the rest and exercise states
Time frame: Intra-procedural
The NHPR difference between the rest and exercise states
Time frame: Intra-procedural
Angina severity score at the angina threshold
Time frame: Intra-procedural
Angina similarity score at the angina threshold
Time frame: Intra-procedural
Angina symptom type at the angina threshold
Time frame: Intra-procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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. This study is not recruiting at the moment.
Rasha Al-Lamee, PhD MRCP principal investigator
Imperial College London
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina, run by Imperial College London at 6 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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiyyaz Ahmed-Jushuf, MBBS MRCP (020 7594 5735, fiyyaz.ahmed-jushuf09@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The FFR and NHPR value at which the patient experiences angina in a rest state (time frame: Intra-procedural). The study lists 2 primary outcomes in all. 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 6 Mar 2024.