Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack (OCT-RISK)
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.
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 Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bournemouth, United Kingdom
- Royal Bournemouth Hospital
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London, United Kingdom, SE5 9RS
- King's College Hospital
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London, United Kingdom, SE1 7EH
- St Thomas' Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Standard of care
Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease.
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Non-culprit coronary arteries
Other Names:
1.5T
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change in mean fibrous cap thickness measured by optical coherence tomography
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in mean lipid arc measured by optical coherence tomography
Time Frame: 6 months
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6 months
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Presence of thin cap fibroatheroma measured by optical coherence tomography
Time Frame: 6 months
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Plaque with lipid arc >90° and fibrous cap thickness ≤65µm
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6 months
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Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography
Time Frame: 0 and 6 months
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Comparison between non-invasive and invasively derived measures
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0 and 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Non-culprit major adverse cardiac events
Time Frame: 6 months and 36 months
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Death, myocardial infarction, ischaemia driven revascularisation
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6 months and 36 months
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Change in vessel stenosis measured by optical coherence tomography and magnetic resonance angiography
Time Frame: 0, 6 and 36 months
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Comparison between non-invasive and invasively derived measures
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0, 6 and 36 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Divaka Perera, MD, King's College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Infarction
- Necrosis
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Infarction
- Ischemia
- Pathological Conditions, Signs and Symptoms
- ST Elevation Myocardial Infarction
- Coronary Artery Disease
- Myocardial Ischemia
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Tomography, Optical
- Optical Imaging
- Tomography, Optical Coherence
Other Study ID Numbers
- 292740
- FS/CRTF/22/24342 (Other Grant/Funding Number: British Heart Foundation)
- RE/18/2/34213 (Other Grant/Funding Number: British Heart Foundation)
- COR- 2021-000193 (Other Grant/Funding Number: Abbott Vascular)
- NIHR203323 (Other Grant/Funding Number: National Institute for Health and Care Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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