Coronary Artery DiseaseOCT-RISKNCT05781087
Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack
An observational study of Coronary Artery Disease and ST Elevation Myocardial Infarction, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, ST Elevation Myocardial Infarction, Ischemic Heart Disease
- What is being tested?
- Optical coherence tomography and pressure wire assessment and Cardiac magnetic resonance angiogram
- How many people
- 90 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 25 Apr 2023to 1 Sep 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after presentation with ST elevation myocardial infarction.
Who may be able to join
- Successful primary percutaneous coronary intervention (PCI) within the previous week with no major complications at the index procedure
- Bystander disease in a non-culprit vessel planned for clinically indicated staged angiography +/- PCI
- Able to provide written informed consent.
Who cannot join
- Cardiogenic shock requiring intubation, inotropes or a mechanical support device
- Creatinine clearance <30ml/min
- Prior coronary artery bypass grafting
- Life expectancy less than 3 years
- Pregnancy.
- Target lesion in the left main coronary artery
- Severe calcification or tortuosity that would threaten safe placement of a pressure wire or OCT catheter
- Chronic total occlusion of a major epicardial vessel.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Bournemouth Hospital
Bournemouth
St Thomas' Hospital
London, SE1 7EH
King's College Hospital
London, SE5 9RS
About this study
Official title: Optical Coherence Tomography With Magnetic Resonance Angiography to Assess STEMI Non-culprit Risk
Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time.
Although in general people do better if these non-culprit narrowings are also treated with stents if they look severe, this process has problems. This is because narrowings that look severe may be stable and not cause any trouble. For these people a stent is a wasted procedure and unnecessary risk. On the other hand, narrowings that are currently left alone because they appear mild, may progress and cause a heart attack.
Read more
Participants who have had a heart attack will have a scan from inside the heart arteries during an angiogram (optical coherence tomography, OCT) and a magnetic resonance angiogram (MRA).
If the investigators can show that it is possible to accurately predict which non-culprit narrowings are going to progress and which are going to stabilise, medical professionals may be able to better target their treatments after a heart attack.
- Being tested
- Optical coherence tomography and pressure wire assessment, Cardiac magnetic resonance angiogram
- Keywords
- optical coherence tomography, non-culprit, magnetic resonance imaging, cardiac magnetic resonance, STEMI, magnetic resonance angiography, OCT
- Medical subject headings
- Coronary Artery Disease, ST Elevation Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography and pressure wire assessmentDiagnostic test
Also called OCT (Abbott), PressureWire X (Abbott)
Non-culprit coronary arteries
Cardiac magnetic resonance angiogramDiagnostic test
Also called Cardiac MRI
1.5T
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease. Receives: Diagnostic Test: Optical coherence tomography and pressure wire assessment; Diagnostic Test: Cardiac magnetic resonance angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean fibrous cap thickness measured by optical coherence tomography
Measured: 6 months
Secondary outcomes (3)
Change in mean lipid arc measured by optical coherence tomography
Measured: 6 months
Presence of thin cap fibroatheroma measured by optical coherence tomography
Plaque with lipid arc >90° and fibrous cap thickness ≤65µm
Measured: 6 months
Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography
Comparison between non-invasive and invasively derived measures
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start25 Apr 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Divaka Perera, MD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781087
- Sponsor's protocol ID
- 292740
- Other IDs
- FS/CRTF/22/24342, RE/18/2/34213, COR- 2021-000193, NIHR203323
- Acronym
- OCT-RISK
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2023
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography With Magnetic Resonance Angiography to Assess STEMI Non-culprit Risk
- ClinicalTrials.gov ID
- NCT05781087
- Acronym / sponsor ID
- OCT-RISK / 292740
- Keywords
- optical coherence tomography, non-culprit, magnetic resonance imaging, cardiac magnetic resonance, STEMI, magnetic resonance angiography, OCT
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, Imperial College London
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 23 Mar 2023 (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.
Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time.
Although in general people do better if these non-culprit narrowings are also treated with stents if they look severe, this process has problems. This is because narrowings that look severe may be stable and not cause any trouble. For these people a stent is a wasted procedure and unnecessary risk. On the other hand, narrowings that are currently left alone because they appear mild, may progress and cause a heart attack.
Participants who have had a heart attack will have a scan from inside the heart arteries during an angiogram (optical coherence tomography, OCT) and a magnetic resonance angiogram (MRA).
If the investigators can show that it is possible to accurately predict which non-culprit narrowings are going to progress and which are going to stabilise, medical professionals may be able to better target their treatments after a heart attack.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care | – | Diagnostic Test: Optical coherence tomography and pressure wire assessment, Diagnostic Test: Cardiac magnetic resonance angiogramPatients after ST-elevation myocardial infarction with non-culprit coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after presentation with ST elevation myocardial infarction.
Key inclusion criteria (3 listed)
- Successful primary percutaneous coronary intervention (PCI) within the previous week with no major complications at the index procedure
- Bystander disease in a non-culprit vessel planned for clinically indicated staged angiography +/- PCI
- Able to provide written informed consent.
Key exclusion criteria (8 listed)
- Cardiogenic shock requiring intubation, inotropes or a mechanical support device
- Creatinine clearance <30ml/min
- Prior coronary artery bypass grafting
- Life expectancy less than 3 years
- Pregnancy.
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 |
|---|---|---|
| Optical coherence tomography and pressure wire assessmentAlso: OCT (Abbott), PressureWire X (Abbott)Non-culprit coronary arteries | Diagnostic test | Standard of care |
| Cardiac magnetic resonance angiogramAlso: Cardiac MRI1.5T | Diagnostic test | Standard of care |
Primary outcome
Change in mean fibrous cap thickness measured by optical coherence tomography
Time frame: 6 months
3 secondary outcomes
Change in mean lipid arc measured by optical coherence tomography
Time frame: 6 months
Presence of thin cap fibroatheroma measured by optical coherence tomography
Time frame: 6 months
Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography
Time frame: 0 and 6 months
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 16 Jun 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.
Divaka Perera, MD principal investigator
King's College London
3 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 ST Elevation Myocardial Infarction, run by Guy's and St Thomas' NHS Foundation Trust at 3 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 8 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Change in mean fibrous cap thickness measured by optical coherence tomography (time frame: 6 months). 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 16 Jun 2026.