N/A
N=706
Prediction of Recurrent Events With 18F-Fluoride
Coronary Artery Disease · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT02278211 ↗Enrolled (actual)
706
Serious AEs
0.3%
Results posted
Mar 2025
Primary outcome: Primary: Cardiac Death, Non-fatal Recurrent Myocardial Infarction or Unscheduled Coronary Revascularisation — 51; 90 Participants — p=0.20
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Edinburgh
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Death, Non-fatal Recurrent Myocardial Infarction or Unscheduled Coronary Revascularisation |
51; 90 | 0.20 |
| SECONDARY All Cause Death |
9; 30 | 0.02 sig |
| SECONDARY Each Individual Component End-point of the Composite End-point of Major Adverse Cardiac Event |
2; 10; 17; 37; 36; 51 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Patients aged ≥50 years with recent ( 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
Data sourced from ClinicalTrials.gov (NCT02278211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.