PET MRI in Coronary Artery Disease

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: MRI; Diagnostic Test: PET/MRI

• Registration Number: NCT03451448
• Lead Sponsor: University of Edinburgh

Brief Summary

This study will assess the use of position emission tomography/magnetic resonance imaging (PET/MRI) using ultra-small-superparamagnetic particles of iron oxide (USPIO) as a contrast agent in patients with coronary artery disease.

Detailed Description

Positron emission tomography/magnetic resonance imaging (PET/MRI) has the potential to provide detailed information on coronary artery anatomy, the presence of coronary artery stenosis, the composition of atherosclerotic plaque using MRI tissue characterisation and information about the underlying biological processes using targeted PET tracers. Ultra-small-superparamagnetic particles of iron oxide (USPIO) have a long blood pool half-life so are an ideal contrast agent for PET/MRI imaging.

This study will assess the use of PET/MRI with USPIO in patients with stable coronary artery disease and recent acute myocardial infarction.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-03-01
• Primary Completion: 2023-05-01
• Study Completion: 2024-01-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Healthy volunteers to undergo MRI imaging will be over the age of 18 years and able to provide informed consent.
• Patients with coronary artery disease to undergo PET/MRI will have multi-vessel disease (≥2 vessel coronary artery disease with ≥ 50% cross-sectional luminal stenosis).
• able to provide informed consent
• over the age of 40 years

Exclusion Criteria

• inability or unwillingness to undergo magnetic resonance imaging or positron emission tomography
• renal failure (Serum creatinine >200 umol/L or estimated glomerular filtration rate <30 mL/min
• hepatic failure
• pregnancy
• inability to provide informed consent
• contraindications to undergoing MRI scanning
• contraindications to contrast agents not included above including evidence of iron overload, known allergy to constituents of the contrast agents, and anaemia not caused by iron deficiency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	MRI	Healthy volunteers to undergo MRI using USPIO contrast
Stable coronary artery disease	PET/MRI	Patients with coronary artery disease without recent (3 months) acute coronary syndrome or revascularisation
Recent acute coronary syndrome	PET/MRI	Patients with recent (3 months) type 1 myocardial infarction

Primary Outcome Measures

Name	Time	Method
PET/MRI findings	Immediately after PET/MRI scan	The primary endpoint will be the difference in MRI and PET characteristics of atherosclerotic plaques in patients with and without recent acute coronary syndromes.

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Scotland, United Kingdom