PREFFIR - Prediction of Recurrent Events with 18F-Fluoride

Phase 1

• Conditions: Cardiovascular Disease; MedDRA version: 20.0Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866; MedDRA version: 20.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004021-41-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-21
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 700

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

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.Permanent or persistent atrial fibrillation
7.Previous screening as part of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified