Prediction of Recurrent Events With 18F-Fluoride

Coronary Artery Disease Clinical Trial

— PREFFIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278211
• Other study ID #: PREFFIR
• Status: Completed
• Start date: October 2015
• Est. completion date: May 2022

Study information

• Verified date: June 2022
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The investigators will then perform long-term follow-up of these patients to determine the prognostic significance of coronary 18F-NaF uptake

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United Kingdom	Edinburgh Heart Centre	Edinburgh	Lothian

Sponsors (6)

Lead Sponsor	Collaborator
University of Edinburgh	Manchester University NHS Foundation Trust, NHS Grampian, NHS Lothian, Oxford University Hospitals NHS Trust, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View Citation

Derlin T, Tóth 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	All cause death		2 years
Secondary	Recurrent major adverse cardiac events defined as cardiac death, recurrent myocardial infarction, and rehospitalization for acute coronary syndrome, unscheduled coronary revascularization		2 years
Secondary	Healthcare resource utilization of patients with and without focal 18F-NaF uptake in coronary plaques unrelated to index myocardial infarction	Whether the presence of 18F-NaF uptake in non-culprit plaques is related to increased healthcare resource utilisation over time.	2 years
Secondary	Each individual component end-point of the composite end-point of major adverse cardiac event		2 years
Secondary	18F-NaF uptake localisation to culprit plaque causing the index myocardial infarction	Whether 18F-NaF uptake localises to the culprit plaque responsible for the index myocardial infarction	3 weeks
Secondary	Territory of subsequent myocardial reinfarction in patients with focal 18F-NaF uptake in coronary plaques unrelated to index myocardial infarction	Whether there is detectable 18F-NaF uptake in coronary plaques which are not the culprit related to the index MI but are potentially the cause of subsequent MI as determined by the territory of the subsequent MI corresponding with myocardium supplied by the artery with initial 18F-NaF uptake	2 years
Secondary	Coronary artery plaque progression by computed tomography coronary angiography. Plaque volume, composition and calcification		2 years