Prediction of Recurrent Events With 18F-Fluoride

Study Overview
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Brief Summary
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This is a multi-centre observational study. It will make use of the positron emission tomography (PET) tracer 18F-sodium fluoride (18F-NaF) as a marker of coronary plaque vulnerability to detect culprit and non-culprit unstable coronary plaques in patients with recent myocardial infarctions. The investigators will then perform long-term follow-up of these patients to determine the prognostic significance of coronary 18F-NaF uptake

Detailed Description
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The investigators intend to recruit 700 patients hospitalised with myocardial infarction and proven multivessel coronary artery disease. All patients will undergo a combined CT coronary angiogram (CTCA) and PET scan using 18F-NaF as a tracer. Patients will then have clinical follow-up before undergoing a repeat CTCA at 2 years to assess progression of coronary disease. Clinical review of all patients will continue until study completion (given 2 years of recruitment this is likely to last 4 years) and following this the investigators will continue to monitor for further cardiovascular events via review of patient electronic health records for a further 5 years.

Official Title
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Prediction of Recurrent Events With 18F-Fluoride to Identify Ruptured and High-risk Coronary Artery Plaques in Patients With Myocardial Infarction

Conditions
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Coronary Artery Disease, Myocardial Infarction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥50 years with recent (<21 days) type 1 myocardial infarction and angiographically proven multi-vessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery). Provision of informed consent prior to any study specific procedures Exclusion Criteria: Inability or unwilling to give informed consent Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial Major intercurrent illness with life expectancy <2 year Renal dysfunction (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) Contraindication to iodinated contrast agent, positron emission tomography or computed tomography Atrial fibrillation Previous recruitment into the trial

Ages Eligible for Study
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Minimum Age: 50 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 |
| --- | --- |
| Study Cohort<br>Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death, non-fatal recurrent myocardial infarction or unscheduled coronary revascularisation | To determine whether coronary 18F-fluoride uptake is associated with major adverse cardiac events in patients with multi-vessel coronary artery disease and recent myocardial infarction. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | 2 years | 
| Recurrent major adverse cardiac events defined as cardiac death, recurrent myocardial infarction, and rehospitalization for acute coronary syndrome, unscheduled coronary revascularization |  | 2 years | 
| Healthcare resource utilization of patients with and without focal 18F-NaF uptake in coronary plaques unrelated to index myocardial infarction | Whether the presence of 18F-NaF uptake in non-culprit plaques is related to increased healthcare resource utilisation over time. | 2 years | 
| Each individual component end-point of the composite end-point of major adverse cardiac event |  | 2 years | 
| 18F-NaF uptake localisation to culprit plaque causing the index myocardial infarction | Whether 18F-NaF uptake localises to the culprit plaque responsible for the index myocardial infarction | 3 weeks | 
| Territory of subsequent myocardial reinfarction in patients with focal 18F-NaF uptake in coronary plaques unrelated to index myocardial infarction | Whether there is detectable 18F-NaF uptake in coronary plaques which are not the culprit related to the index MI but are potentially the cause of subsequent MI as determined by the territory of the subsequent MI corresponding with myocardium supplied by the artery with initial 18F-NaF uptake | 2 years | 
| Coronary artery plaque progression by computed tomography coronary angiography. Plaque volume, composition and calcification |  | 2 years |