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NCT03451448 Clinical Trial

PET MRI in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:
Combined Magnetic Resonance Coronary Angiography and Positron Emission Tomography in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03451448
Other study ID # 17/SS/0151
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date January 31, 2024

Study information
Verified date May 2024
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date January 31, 2024
Est. primary completion date May 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PET/MRI
PET/MRI with USPIO contrast
• MRI
MRI with USPIO contrast

Locations
Country Name City State
United Kingdom Royal Infirmary of Edinburgh Edinburgh Scotland

Sponsors (1)
Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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