Angina, StableORACLENCT06325020
Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
An observational study of Angina, Stable and Coronary Artery Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Angina, Stable, Coronary Artery Disease
- What is being tested?
- The assessment of patients with possible angina using the ORACLE pathway
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2024to 31 Dec 2026
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to the rapid access chest pain service within NHS Lothian will be eligible to participate in our feasibility study.
Who may be able to join
- >30 years of age
- Referral to the rapid access chest pain clinic with possible new onset or worsening angina
Who cannot join
- Inability to give informed consent.
- Previous recruitment to the study.
- Acute coronary syndrome within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ORACLE: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services.
The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral.
Read more
Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.
Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay.
The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events.
Read the detailed description
Recent onset of angina is a clinical manifestation of unstable or progressive coronary artery disease and is a common presentation within primary care. Evaluation can be challenging as access to objective measures of risk and diagnostic testing are limited in this setting. Due to capacity, not all patients referred to the rapid access chest pain clinic can be reviewed within this clinic.
Patients are often high risk with suspected obstructive coronary artery disease, and the aim should be for review, assessment and if required, initiation of therapy, without undue delay.
This study has been designed to explore the feasibility of delivering a virtual chest pain assessment for patients with new onset chest pain. It is an observational cohort study, that uses a combination of digital tools to capture relevant patient information and clinical history, point-of-care high-sensitivity cardiac troponin testing and electrocardiography.
This pathway will aim to provide an objective assessment of risk on the next working day following primary care contact to all patients referred to the rapid access chest pain clinic.
On completion of this assessment patients will be stratified to low, intermediate or high risk groups based on their symptoms, risk factors, point of care troponin value (ng/l) and ECG. The results will not be made available to the clinical team unless the patients was at risk of harm (acute coronary syndrome or arrhythmia). Patients will return to receive routine clinical care.
The investigators plan to recruit 300 participants or for six months, whatever arises first. Participants can only be recruited once during the study period.
- Conditions
- Angina, Stable, Coronary Artery Disease
- Being tested
- The assessment of patients with possible angina using the ORACLE pathway
- Keywords
- angina, chest pain, cardiac troponin, risk stratification
- Medical subject headings
- Angina, Stable, Coronary Artery Disease, Angina Pectoris, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The assessment of patients with possible angina using the ORACLE pathwayOther
Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.
Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured.
The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events.
| Study group | Role | What they receive |
|---|---|---|
| Patients with possible angina | Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.
Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured.
The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events. Receives: Other: The assessment of patients with possible angina using the ORACLE pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral.
The proportion of participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in whom a complete risk assessment is delivered in a community setting using point of care and patient facing technologies within one working day of referral.
Measured: This is the time from referral to rapid access chest pain clinic through to completion of their visit, anticipated to be between 1 and 3 days.
Secondary outcomes (7)
Proportion of patients who can have their risk assessment completed in one, two or three or more working days from referral to service until completion of risk assessment.
The proportion of participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in whom a complete risk assessment is delivered in a community setting using point of care and patient facing technologies within one, two or three or more working days of referral.
Measured: This is the time from referral to rapid access chest pain clinic through to completion of their visit, anticipated to be between 1 and 3 days.
Proportion of valid and interpretable point-of-care troponin tests
This will be the proportion of patients in whom a valid high sensitivity cardiac troponin result can be obtained from undertaking the point of care assay.
Measured: This will be completed during the patients study visit, anticipated to last 1 hour
Proportion of personal electrocardiograms that are interpretable
This will be the proportion of patients in whom an interpretable personal ECG has been performed
Measured: This will be completed during the patients study visit, anticipated to last 1 hour
Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification.
This will be the proportion of patients who are stratified into low, intermediate or high risk groups on completion of their risk assessment.
Measured: This will be completed during the patients study visit, anticipated to last 1 hour
Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status.
This will be the proportion of patients who do and do not receive a clinical diagnosis of angina and this will be stratified by triage status
Measured: This will be obtained at 3 months following completion of the patient's assessment.
Proportion of participants with unscheduled Emergency Department attendance(s) at 3 months stratified as low, intermediate, or high risk and according to triage status.
This will be the proportion of patients who present acutely to the emergency department in the 3 months following assessment. This will be stratified by risk stratification and their clinical triage status.
Measured: This will be obtained at 3 months following completion of the patient's assessment.
Proportion of participants with cardiac death or non-fatal myocardial infarction at 3 months stratified as low, intermediate, or high risk and according to triage.
This will be the proportion of patients who have cardiac death or fatal myocardial infarction in the 3 months following assessment. This will be stratified by risk stratification and their clinical triage status.
Measured: This will be obtained at 3 months following completion of the patient's assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start4 Jul 2024
- Primary completion21 Jul 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, StableStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael McDermott, MBCHB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325020
- Sponsor's protocol ID
- 337367
- Acronym
- ORACLE
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORACLE: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
- ClinicalTrials.gov ID
- NCT06325020
- Acronym / sponsor ID
- ORACLE / 337367
- Conditions
- Angina, Stable, Coronary Artery Disease
- Keywords
- angina, chest pain, cardiac troponin, risk stratification
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Mar 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.
The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services.
The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral.
Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.
Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay.
The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events.
Detailed description
Recent onset of angina is a clinical manifestation of unstable or progressive coronary artery disease and is a common presentation within primary care. Evaluation can be challenging as access to objective measures of risk and diagnostic testing are limited in this setting. Due to capacity, not all patients referred to the rapid access chest pain clinic can be reviewed within this clinic.
Patients are often high risk with suspected obstructive coronary artery disease, and the aim should be for review, assessment and if required, initiation of therapy, without undue delay.
This study has been designed to explore the feasibility of delivering a virtual chest pain assessment for patients with new onset chest pain. It is an observational cohort study, that uses a combination of digital tools to capture relevant patient information and clinical history, point-of-care high-sensitivity cardiac troponin testing and electrocardiography.
This pathway will aim to provide an objective assessment of risk on the next working day following primary care contact to all patients referred to the rapid access chest pain clinic.
On completion of this assessment patients will be stratified to low, intermediate or high risk groups based on their symptoms, risk factors, point of care troponin value (ng/l) and ECG. The results will not be made available to the clinical team unless the patients was at risk of harm (acute coronary syndrome or arrhythmia). Patients will return to receive routine clinical care.
The investigators plan to recruit 300 participants or for six months, whatever arises first. Participants can only be recruited once during the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with possible angina | – | Other: The assessment of patients with possible angina using the ORACLE pathwayParticipants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms. Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured. The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the rapid access chest pain service within NHS Lothian will be eligible to participate in our feasibility study.
Key inclusion criteria (2 listed)
- >30 years of age
- Referral to the rapid access chest pain clinic with possible new onset or worsening angina
Key exclusion criteria (3 listed)
- Inability to give informed consent.
- Previous recruitment to the study.
- Acute coronary syndrome within 3 months.
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 |
|---|---|---|
| The assessment of patients with possible angina using the ORACLE pathwayParticipants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms. Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured. The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events. | Other | Patients with possible angina |
Primary outcome
Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral.
Time frame: This is the time from referral to rapid access chest pain clinic through to completion of their visit, anticipated to be between 1 and 3 days.
The proportion of participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in whom a complete risk assessment is delivered in a community setting using point of care and patient facing technologies within one working day of referral.
7 secondary outcomes
Proportion of patients who can have their risk assessment completed in one, two or three or more working days from referral to service until completion of risk assessment.
Time frame: This is the time from referral to rapid access chest pain clinic through to completion of their visit, anticipated to be between 1 and 3 days.
Proportion of valid and interpretable point-of-care troponin tests
Time frame: This will be completed during the patients study visit, anticipated to last 1 hour
Proportion of personal electrocardiograms that are interpretable
Time frame: This will be completed during the patients study visit, anticipated to last 1 hour
Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification.
Time frame: This will be completed during the patients study visit, anticipated to last 1 hour
Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status.
Time frame: This will be obtained at 3 months following completion of the patient's assessment.
Proportion of participants with unscheduled Emergency Department attendance(s) at 3 months stratified as low, intermediate, or high risk and according to triage status.
Time frame: This will be obtained at 3 months following completion of the patient's assessment.
Proportion of participants with cardiac death or non-fatal myocardial infarction at 3 months stratified as low, intermediate, or high risk and according to triage.
Time frame: This will be obtained at 3 months following completion of the patient's assessment.
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 7 Apr 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. This study is not recruiting at the moment.
Michael McDermott, MBCHB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina, Stable and Coronary Artery Disease, run by University of Edinburgh at 1 site 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral. (time frame: This is the time from referral to rapid access chest pain clinic through to completion of their visit, anticipated to be between 1 and 3 days.). 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 7 Apr 2026.