PET MRI in Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03451448
Recruitment Status : Not yet recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: PET/MRI Diagnostic Test: MRI

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
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Combined Magnetic Resonance Coronary Angiography and Positron Emission Tomography in Patients With Coronary Artery Disease
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  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.

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03451448

Contact: Michelle Williams 01312421000

Sponsors and Collaborators
University of Edinburgh
Principal Investigator: Michelle Williams University of Edinburgh

Responsible Party: University of Edinburgh Identifier: NCT03451448     History of Changes
Other Study ID Numbers: 17/SS/0151
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Edinburgh:
ultra-small-superparamagnetic particles

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases