PET MRI in Coronary Artery Disease

May 20, 2024 updated by: University of Edinburgh

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

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
    • Scotland
      • Edinburgh, Scotland, United Kingdom
        • Royal Infirmary of Edinburgh

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers to undergo MRI.

Patients with stable coronary artery disease or recent acute myocardial infarction to undergo PET/MRI

Description

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after PET/MRI scan

Collaborators and Investigators

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

Sponsor

University of Edinburgh

Investigators

  • Principal Investigator: Michelle Williams, University of Edinburgh

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 (Actual)

February 1, 2018

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/SS/0151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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