PET MRI in Coronary Artery Disease

NCT ID: NCT03451448

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

Healthy volunteers to undergo MRI using USPIO contrast

MRI

Intervention Type DIAGNOSTIC_TEST

MRI with USPIO contrast

Stable coronary artery disease

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

PET/MRI

Intervention Type DIAGNOSTIC_TEST

PET/MRI with USPIO contrast

Recent acute coronary syndrome

Patients with recent (3 months) type 1 myocardial infarction

PET/MRI

Intervention Type DIAGNOSTIC_TEST

PET/MRI with USPIO contrast

Interventions

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PET/MRI

PET/MRI with USPIO contrast

Intervention Type DIAGNOSTIC_TEST

MRI

MRI with USPIO contrast

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Williams

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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17/SS/0151

Identifier Type: -

Identifier Source: org_study_id

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