Prediction of Recurrent Events With 18F-Fluoride (PREFFIR)

June 10, 2022 updated by: University of Edinburgh

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

706

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Edinburgh Heart Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study Cohort
Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause death
Time Frame: 2 years
2 years
Recurrent major adverse cardiac events defined as cardiac death, recurrent myocardial infarction, and rehospitalization for acute coronary syndrome, unscheduled coronary revascularization
Time Frame: 2 years
2 years
Healthcare resource utilization of patients with and without focal 18F-NaF uptake in coronary plaques unrelated to index myocardial infarction
Time Frame: 2 years
Whether the presence of 18F-NaF uptake in non-culprit plaques is related to increased healthcare resource utilisation over time.
2 years
Each individual component end-point of the composite end-point of major adverse cardiac event
Time Frame: 2 years
2 years
18F-NaF uptake localisation to culprit plaque causing the index myocardial infarction
Time Frame: 3 weeks
Whether 18F-NaF uptake localises to the culprit plaque responsible for the index myocardial infarction
3 weeks
Territory of subsequent myocardial reinfarction in patients with focal 18F-NaF uptake in coronary plaques unrelated to index myocardial infarction
Time Frame: 2 years
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
Coronary artery plaque progression by computed tomography coronary angiography. Plaque volume, composition and calcification
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

Wellcome Trust
NHS Lothian
Manchester University NHS Foundation Trust
Oxford University Hospitals NHS Trust
NHS Grampian

Investigators

  • Study Director: David Newby, PhD, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREFFIR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe