Coronary Artery DiseaseORBITA-STARNCT04280575
Symptomatic Trial of Angina Assessment Prior to Revascularization
An observational study of Coronary Artery Disease and Angina, Stable, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Angina, Stable
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Jan 2020to 1 May 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with single-vessel coronary artery disease with symptoms of stable angina
Who may be able to join
- Angina or angina-equivalent symptoms
- Anatomical evidence of a significant single vessel coronary stenosis on diagnostic coronary angiography indicating ≥ 70% stenosis
- Referred for percutaneous coronary intervention for treatment of stable angina
Who cannot join
- Age younger than 18
- Age older than 85
- Recent acute coronary syndrome
- Multivessel coronary artery disease
- Previous coronary artery bypass graft surgery
- Significant left main stem coronary disease
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- Chronic total occlusion in the target vessel
- Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
- Contraindication to antiplatelet therapy
- Contraindication to adenosine infusion
- Severe valvular disease
- Severe LV systolic impairment
- Severe respiratory disease
- Life expectancy less than 2 years, pregnancy, unable to consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Trust
Basildon, Essex
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: Symptomatic Trial of Angina Assessment Prior to Revascularization: A Placebo-controlled Experiment on Symptoms in Stable Coronary Artery Disease
The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI.
- Conditions
- Coronary Artery Disease, Angina, Stable
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Also called PCI
Coronary artery stenting for stable angina
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery
Similarity Score (1-10) (Higher Score = Better Outcome)
Measured: 30 Days
Secondary outcomes (10)
Change in angina symptom score
Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)
Measured: 30 Days
Change in treadmill exercise time
Measured: 30 Days
Change in treadmill time to chest pain
Measured: 30 Days
Angina severity as assessed by Canadian Cardiovascular Society Class
Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)
Measured: 30 Days
Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire.
Seattle Angina Questionnaire, (Lower Score = Better Outcome)
Measured: 30 Days
Quality of Life assessed with the EQ-5D-5L questionnaire
(Lower Score = Better Outcome)
Measured: 30 Days
Change in dobutamine stress echocardiography score
(Lower Score = Better Outcome)
Measured: 30 Days
Need for anti-anginal medication introduction and uptitration
Measured: 30 Days
Anxiety as assessed by the GAD-7 Score
Generalised anxiety and depression - 7 Score. (Lower Score = Better Outcome)
Measured: 30 days
Depression as assessed by the PHQ-9 Score
Patient Health Questionnaire - 9. (Lower Score = Better Outcome)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start16 Jan 2020
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Mid and South Essex NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280575
- Sponsor's protocol ID
- 19HH5060
- Acronym
- ORBITA-STAR
- Status last verified
- Sep 2023
- First submitted
- 13 Feb 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Chotai S, Simader FA, Mohsin M, Salih A, Ganesananthan S, Bual N, Petraco R, Nijjer SS, Sen S, Sehmi J, Ruparelia N, Dungu JN, Kabir A, Tang K, Gamma R, Davies JR, Kotecha T, Cole GD, Howard JP, Keeble TR, Clesham GJ, O'Kane PD, Harrell FE Jr, Francis DP, Shun-Shin MJ, Al-Lamee RK. The Role of the Collateral Circulation in Stable Angina: An Invasive Placebo-Controlled Study. Circulation. 2025 Dec 2;152(22):1541-1551. doi: 10.1161/CIRCULATIONAHA.125.074687. Epub 2025 Oct 27.
PubMed 41144984Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Simader FA, Mohsin M, Ganesananthan S, Nowbar AN, Chotai S, Sen S, Petraco R, Nijjer SS, Sehmi J, Ruparelia N, Dungu JN, Kabir A, Tang K, Gamma R, Davies JR, Kotecha T, Cole GD, Howard JP, Keeble TR, Clesham G, O'Kane PD, Harrell FE Jr, Francis DP, Shun-Shin MJ, Al-Lamee RK. N-of-1 Trial of Angina Verification Before Percutaneous Coronary Intervention. J Am Coll Cardiol. 2024 Jul 2;84(1):1-12. doi: 10.1016/j.jacc.2024.04.001. Epub 2024 May 14.
PubMed 38752902
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Trial of Angina Assessment Prior to Revascularization: A Placebo-controlled Experiment on Symptoms in Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04280575
- Acronym / sponsor ID
- ORBITA-STAR / 19HH5060
- Conditions
- Coronary Artery Disease, Angina, Stable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Mid and South Essex NHS Foundation Trust
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Feb 2020 (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.
The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with single-vessel coronary artery disease with symptoms of stable angina
Key inclusion criteria (3 listed)
- Angina or angina-equivalent symptoms
- Anatomical evidence of a significant single vessel coronary stenosis on diagnostic coronary angiography indicating ≥ 70% stenosis
- Referred for percutaneous coronary intervention for treatment of stable angina
Key exclusion criteria (14 listed)
- Age younger than 18
- Age older than 85
- Recent acute coronary syndrome
- Multivessel coronary artery disease
- Previous coronary artery bypass graft surgery
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 interventionAlso: PCICoronary artery stenting for stable angina | Procedure or surgery | – |
Primary outcome
Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery
Time frame: 30 Days
Similarity Score (1-10) (Higher Score = Better Outcome)
10 secondary outcomes
Change in angina symptom score
Time frame: 30 Days
Change in treadmill exercise time
Time frame: 30 Days
Change in treadmill time to chest pain
Time frame: 30 Days
Angina severity as assessed by Canadian Cardiovascular Society Class
Time frame: 30 Days
Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire.
Time frame: 30 Days
Quality of Life assessed with the EQ-5D-5L questionnaire
Time frame: 30 Days
Change in dobutamine stress echocardiography score
Time frame: 30 Days
Need for anti-anginal medication introduction and uptitration
Time frame: 30 Days
Anxiety as assessed by the GAD-7 Score
Time frame: 30 days
Depression as assessed by the PHQ-9 Score
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 41144984Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Chotai S, Simader FA, Mohsin M, Salih A, Ganesananthan S, Bual N, Petraco R, Nijjer SS, Sen S, Sehmi J, Ruparelia N, Dungu JN, Kabir A, Tang K, Gamma R, Davies JR, Kotecha T, Cole GD, Howard JP, Keeble TR, Clesham GJ, O'Kane PD, Harrell FE Jr, Francis DP, Shun-Shin MJ, Al-Lamee RK. The Role of the Collateral Circulation in Stable Angina: An Invasive Placebo-Controlled Study. Circulation. 2025 Dec 2;152(22):1541-1551. doi: 10.1161/CIRCULATIONAHA.125.074687. Epub 2025 Oct 27.
- Derived from this study: PubMed 38752902Rajkumar CA, Foley MJ, Ahmed-Jushuf F, Simader FA, Mohsin M, Ganesananthan S, Nowbar AN, Chotai S, Sen S, Petraco R, Nijjer SS, Sehmi J, Ruparelia N, Dungu JN, Kabir A, Tang K, Gamma R, Davies JR, Kotecha T, Cole GD, Howard JP, Keeble TR, Clesham G, O'Kane PD, Harrell FE Jr, Francis DP, Shun-Shin MJ, Al-Lamee RK. N-of-1 Trial of Angina Verification Before Percutaneous Coronary Intervention. J Am Coll Cardiol. 2024 Jul 2;84(1):1-12. doi: 10.1016/j.jacc.2024.04.001. Epub 2024 May 14.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angina, Stable, run by Imperial College London at 2 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04280575, which also lists 2 linked publications.
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 22 Sep 2023.