Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack

Study Overview
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Brief Summary
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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.

Official Title
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Optical Coherence Tomography With Magnetic Resonance Angiography to Assess STEMI Non-culprit Risk

Conditions
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Coronary Artery Disease, ST Elevation Myocardial Infarction, Ischemic Heart Disease

Intervention / Treatment
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* Diagnostic Test: Optical coherence tomography and pressure wire assessment
* Diagnostic Test: Cardiac magnetic resonance angiogram


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care<br>Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease. | Diagnostic Test: Optical coherence tomography and pressure wire assessment<br>* Non-culprit coronary arteries<br>* Other names: PressureWire X (Abbott);Diagnostic Test: Cardiac magnetic resonance angiogram<br>* 1.5T<br>* Other names: Cardiac MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean fibrous cap thickness measured by optical coherence tomography |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean lipid arc measured by optical coherence tomography |  | 6 months | 
| Presence of thin cap fibroatheroma measured by optical coherence tomography | Plaque with lipid arc >90° and fibrous cap thickness ≤65µm | 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 | 0 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optical coherence tomography, non-culprit, magnetic resonance imaging, cardiac magnetic resonance, STEMI, magnetic resonance angiography, OCT