Clinical trial NCT02278211: Prediction of Recurrent Events With 18F-Fluoride
Official title: Prediction of Recurrent Events With 18F-Fluoride to Identify Ruptured and High-risk Coronary Artery Plaques in Patients With Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Infarction
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: Oxford University Hospitals NHS Trust
name: Manchester University NHS Foundation Trust
name: NHS Grampian
name: Wellcome Trust
First posted: 2014-10-29
Enrollment: 995
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recent (\<21 days) type 1 myocardial infarction and multi-vessel coronary artery disease

Brief 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Death, Non-fatal Recurrent Myocardial Infarction or Unscheduled Coronary Revascularisation
timeFrame: 2 years
Secondary outcomes:
measure: All Cause Death
timeFrame: 2 years
measure: Each Individual Component End-point of the Composite End-point of Major Adverse Cardiac Event
timeFrame: 2 years
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Edinburgh Heart Centre
state: Lothian
Study officials:
affiliation: University of Edinburgh
name: David Newby, PhD
role: STUDY_DIRECTOR
References:
citation: Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.
citation: Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037.
citation: Mohler ER 3rd, Alavi A, Wilensky RL. (18)F-fluoride imaging for atherosclerosis. J Am Coll Cardiol. 2012 Oct 23;60(17):1711-2; author reply p.1712-3. doi: 10.1016/j.jacc.2012.06.038. No abstract available.
citation: Derlin T, Toth Z, Papp L, Wisotzki C, Apostolova I, Habermann CR, Mester J, Klutmann S. Correlation of inflammation assessed by 18F-FDG PET, active mineral deposition assessed by 18F-fluoride PET, and vascular calcification in atherosclerotic plaque: a dual-tracer PET/CT study. J Nucl Med. 2011 Jul;52(7):1020-7. doi: 10.2967/jnumed.111.087452. Epub 2011 Jun 16.
citation: Derlin T, Richter U, Bannas P, Begemann P, Buchert R, Mester J, Klutmann S. Feasibility of 18F-sodium fluoride PET/CT for imaging of atherosclerotic plaque. J Nucl Med. 2010 Jun;51(6):862-5. doi: 10.2967/jnumed.110.076471. Epub 2010 May 19.
citation: Moss AJ, Doris MK, Andrews JPM, Bing R, Daghem M, van Beek EJR, Forsyth L, Shah ASV, Williams MC, Sellers S, Leipsic J, Dweck MR, Parker RA, Newby DE, Adamson PD. Molecular Coronary Plaque Imaging Using 18F-Fluoride. Circ Cardiovasc Imaging. 2019 Aug;12(8):e008574. doi: 10.1161/CIRCIMAGING.118.008574. Epub 2019 Aug 6.