PET MRI in Coronary Artery Disease

Sponsor
University of Edinburgh (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03451448
Collaborator
(none)
16
1
62.9
0.3

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
16 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Combined Magnetic Resonance Coronary Angiography and Positron Emission Tomography in Patients With Coronary Artery Disease
Actual Study Start Date :
Feb 1, 2018
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Infirmary of Edinburgh Edinburgh Scotland United Kingdom

Sponsors and Collaborators

  • University of Edinburgh

Investigators

  • Principal Investigator: Michelle Williams, University of Edinburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT03451448
Other Study ID Numbers:
  • 17/SS/0151
First Posted:
Mar 1, 2018
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2022