Coronary Artery DiseasePREFFIRNCT02278211

Prediction of Recurrent Events With 18F-Fluoride

An observational study of Coronary Artery Disease and Myocardial Infarction, run by University of Edinburgh at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Coronary Artery Disease, Myocardial Infarction
How many people: 995 participants
Where: 1 siteUnited Kingdom
Study dates: Oct 2015to May 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Edinburgh Heart Centre
Edinburgh, Lothian, EH16 4SA

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Coronary Artery Disease, Myocardial Infarction
Medical subject headings: Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02278211
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years

Secondary outcomes (2)

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.
Measured: 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
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015May 2022

First posted29 Oct 2014 (estimated)
Study startOct 2015
Primary completionMar 2022
Study completionMay 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by University of EdinburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 995 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02278211
Sponsor's protocol ID: PREFFIR
Acronym: PREFFIR
Status last verified: Jun 2022
First submitted: 15 Oct 2014
Last updated: 17 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 24224999
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.
PubMed 22516444
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.
PubMed 23079119
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.
PubMed 21680686
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.
PubMed 20484438
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.
PubMed 31382765

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prediction of Recurrent Events With 18F-Fluoride to Identify Ruptured and High-risk Coronary Artery Plaques in Patients With Myocardial Infarction
ClinicalTrials.gov ID: NCT02278211
Acronym / sponsor ID: PREFFIR / PREFFIR
Conditions: Coronary Artery Disease, Myocardial Infarction
Study type: Observational
Recruitment status: Completed
Enrolment: 995 participants (actual)
Lead sponsor: University of EdinburghUniversity, hospital or other
Collaborators: NHS Lothian, Oxford University Hospitals NHS Trust, Manchester University NHS Foundation Trust, NHS Grampian, Wellcome Trust
Study start: Oct 2015
Primary completion: Mar 2022 (actual)
Study completion: May 2022 (actual)
First posted: 29 Oct 2014 (estimated)
Results: Posted 17 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with recent (<21 days) type 1 myocardial infarction and multi-vessel coronary artery disease

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Cardiac Death, Non-fatal Recurrent Myocardial Infarction or Unscheduled Coronary Revascularisation
Time frame: 2 years
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 secondary outcomes

All Cause Death
Time frame: 2 years
Each Individual Component End-point of the Composite End-point of Major Adverse Cardiac Event
Time frame: 2 years

Results and safety

Results posted to the registry on 17 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Cohort	706	704

Primary outcome: Cardiac Death, Non-fatal Recurrent Myocardial Infarction or Unscheduled Coronary Revascularisation

Time frame: 2 years. Count of participants. Unit: Participants

Measure	Low Coronary Atherosclerotic Plaque Activity n = 283	High Coronary Atherosclerotic Plaque Activity n = 421
Value	51	90

Low Coronary Atherosclerotic Plaque Activity vs High Coronary Atherosclerotic Plaque Activity: Hazard Ratio (HR): 1.25 (95% CI 0.89 to 1.76), p = 0.20, Log Rank

Population analysed: Clinical follow-up was available for all study participants. At study completion, follow-up was available for 693 participants (98.4%). Over a median of 4 years (IQR, 3-5 years), there were 2582 patient-years of follow-up.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause Mortality was monitored for up to 2 years; serious and/or other adverse events were assessed up to 48 hours post PET CT scan. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Cohort	2 of 704 (0.3%)	13 of 704 (1.8%)	39 of 704

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24224999Joshi 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.
Background: PubMed 22516444Dweck 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.
Background: PubMed 23079119Mohler 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.
Background: PubMed 21680686Derlin 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.
Background: PubMed 20484438Derlin 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.
Derived from this study: PubMed 31382765Moss 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Newby, PhD study director

University of Edinburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Myocardial Infarction, run by University of Edinburgh at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Death, Non-fatal Recurrent Myocardial Infarction or Unscheduled Coronary Revascularisation (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02278211, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.