OCT-RISK: Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Standard of care Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease. |
Diagnostic Test: Optical coherence tomography and pressure wire assessment
Non-culprit coronary arteries
Other Names:
Diagnostic Test: Cardiac magnetic resonance angiogram
1.5T
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in mean fibrous cap thickness measured by optical coherence tomography [6 months]
Secondary Outcome Measures
- Change in mean lipid arc measured by optical coherence tomography [6 months]
- Presence of thin cap fibroatheroma measured by optical coherence tomography [6 months]
Plaque with lipid arc >90° and fibrous cap thickness ≤65µm
- Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography [0 and 6 months]
Comparison between non-invasive and invasively derived measures
Other Outcome Measures
- Non-culprit major adverse cardiac events [6 months and 36 months]
Death, myocardial infarction, ischaemia driven revascularisation
- Change in vessel stenosis measured by optical coherence tomography and magnetic resonance angiography [0, 6 and 36 months]
Comparison between non-invasive and invasively derived measures
Eligibility Criteria
Criteria
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
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Able to provide written informed consent.
Exclusion Criteria:
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Cardiogenic shock requiring intubation, inotropes or a mechanical support device
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Creatinine clearance <30ml/min
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Prior coronary artery bypass grafting
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Life expectancy less than 3 years
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Pregnancy.
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Target lesion in the left main coronary artery
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Severe calcification or tortuosity that would threaten safe placement of a pressure wire or OCT catheter
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Chronic total occlusion of a major epicardial vessel.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- King's College London
- King's College Hospital NHS Trust
Investigators
- Principal Investigator: Divaka Perera, MD, King's College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 292740
- FS/CRTF/22/24342