Coronary Artery DiseaseNCT03451448
PET MRI in Coronary Artery Disease
An observational study of Coronary Artery Disease, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PET/MRI and MRI
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers to undergo MRI. Patients with stable coronary artery disease or recent acute myocardial infarction to undergo PET/MRI
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Magnetic Resonance Coronary Angiography and Positron Emission Tomography in Patients With Coronary Artery Disease
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- PET/MRI, MRI
- Keywords
- PET/MRI, ultra-small-superparamagnetic particles
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDiagnostic test
PET/MRI with USPIO contrast
MRIDiagnostic test
MRI with USPIO contrast
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers to undergo MRI using USPIO contrast Receives: Diagnostic Test: MRI | |
| Stable coronary artery disease | Patients with coronary artery disease without recent (3 months) acute coronary syndrome or revascularisation Receives: Diagnostic Test: PET/MRI | |
| Recent acute coronary syndrome | Patients with recent (3 months) type 1 myocardial infarction Receives: Diagnostic Test: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after PET/MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Feb 2018
- Primary completion1 May 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Williams, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451448
- Sponsor's protocol ID
- 17/SS/0151
- Status last verified
- May 2024
- First submitted
- 23 Feb 2018
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Magnetic Resonance Coronary Angiography and Positron Emission Tomography in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03451448
- Acronym / sponsor ID
- 17/SS/0151
- Conditions
- Coronary Artery Disease
- Keywords
- PET/MRI, ultra-small-superparamagnetic particles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: MRIHealthy volunteers to undergo MRI using USPIO contrast |
| Stable coronary artery disease | – | Diagnostic Test: PET/MRIPatients with coronary artery disease without recent (3 months) acute coronary syndrome or revascularisation |
| Recent acute coronary syndrome | – | Diagnostic Test: PET/MRIPatients with recent (3 months) type 1 myocardial infarction |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers to undergo MRI. Patients with stable coronary artery disease or recent acute myocardial infarction to undergo PET/MRI
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRIPET/MRI with USPIO contrast | Diagnostic test | Recent acute coronary syndrome, Stable coronary artery disease |
| MRIMRI with USPIO contrast | Diagnostic test | Healthy volunteers |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Williams principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET/MRI findings (time frame: Immediately after PET/MRI scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.