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Completed

NCT Number: NCT03451448

PET MRI in Coronary Artery Disease

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/MRI

Diagnostic Test

PET/MRI with USPIO contrast

MRI

Diagnostic Test

MRI with USPIO contrast

Primary outcomes

  1. PET/MRI findings

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Combined Magnetic Resonance Coronary Angiography and Positron Emission Tomography in Patients With Coronary Artery Disease

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Mar 1, 2018
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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