NCT03451448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

5.2 years

First QC Date

February 23, 2018

Last Update Submit

May 20, 2024

Conditions

Keywords

PET/MRIultra-small-superparamagnetic particles

Outcome Measures

Primary Outcomes (1)

  • PET/MRI findings

    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

Study Arms (3)

Healthy volunteers

Healthy volunteers to undergo MRI using USPIO contrast

Diagnostic Test: MRI

Stable coronary artery disease

Patients with coronary artery disease without recent (3 months) acute coronary syndrome or revascularisation

Diagnostic Test: PET/MRI

Recent acute coronary syndrome

Patients with recent (3 months) type 1 myocardial infarction

Diagnostic Test: PET/MRI

Interventions

PET/MRIDIAGNOSTIC_TEST

PET/MRI with USPIO contrast

Recent acute coronary syndromeStable coronary artery disease
MRIDIAGNOSTIC_TEST

MRI with USPIO contrast

Healthy volunteers

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Michelle Williams

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

February 1, 2018

Primary Completion

May 1, 2023

Study Completion

January 31, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Locations