Prediction of Recurrent Events With 18F-Fluoride

University of Edinburgh995 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

995

Conditions

Coronary Artery Disease Myocardial Infarction

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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). 2. Provision of informed consent prior to any study specific procedures Exclusion Criteria: 1. Inability or unwilling to give informed consent 2. 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 3. Major intercurrent illness with life expectancy \<2 year 4. Renal dysfunction (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) 5. Contraindication to iodinated contrast agent, positron emission tomography or computed tomography 6. Atrial fibrillation 7. Previous recruitment into the trial

Locations (1)

Edinburgh Heart Centre

Edinburgh, Lothian, United Kingdom

Outcomes

Primary Outcomes

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. Participants were followed up by site investigators until the last recruited patient had completed their 2-year follow-up visit.

Time frame: 2 years

Secondary Outcomes

All Cause Death

All cause death. Participants were followed up by site investigators until the last recruited patient had completed their 2-year follow-up visit.

Time frame: 2 years

Each Individual Component End-point of the Composite End-point of Major Adverse Cardiac Event

Cardiac death, Nonfatal myocardial infarction, Unscheduled coronary revascularization

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.