Prediction of Recurrent Events With 18F-Fluoride

NCT02278211 | Completed Results

• 1 other identifier: PREFFIR
• Study Type: observational
• Target: 995
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• All Cause Death

  2 years

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

  2 years

Study Arms (2)

Low Coronary Atherosclerotic Plaque Activity

Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease found to have Low Coronary Atherosclerotic Plaque Activity in PET CT scan

High Coronary Atherosclerotic Plaque Activity

Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease found to have High Coronary Atherosclerotic Plaque Activity in PET CT scan

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recent (\<21 days) type 1 myocardial infarction and multi-vessel coronary artery disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Manchester University NHS Foundation Trust: collaborator
• NHS Grampian: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Edinburgh Heart Centre

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 24224999 BACKGROUND

• 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.

  PMID: 22516444 BACKGROUND

• 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.

  PMID: 23079119 BACKGROUND

• 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.

  PMID: 21680686 BACKGROUND

• 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.

  PMID: 20484438 BACKGROUND

• 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.

  PMID: 31382765 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Limitations and Caveats

We had a lower than anticipated event rate in the study population. This led us to change our primary end point to include unscheduled coronary revascularization. Our study was a longitudinal cohort study, we could only assess associations rather than causality. Low inclusion of women, reflects the lower proportion of women who present with ST-segment elevation MI.

Results Point of Contact

• Title: Professor Dave Newby
• Organization: University of Edinburgh

D.E.Newby@ed.ac.uk

0131 242 6515

Study Officials

• David Newby, PhD

  University of Edinburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 29, 2014
• Study Start: October 1, 2015
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2022-06

Locations

GB (1)