Myocardial InfarctionNCT03252990
18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability
An observational study of Myocardial Infarction and Myocardial Ischemia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This study is designed as a prospective observational feasibility study. The investigators will study whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques and whether the culprit plaque shows a locally increased uptake of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Myocardial Ischemia, Atherosclerosis
- What is being tested?
- PET-MRI and Optical Coherence Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Mar 2018to 6 Dec 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: See 'Group descriptions'
Group 1 - Protocol optimization: only additional PET-MRI
- Diagnosed with stable angina pectoris and scheduled for a PCI procedure at the MUMC
- Minimum age of 18 years
- Mentally competent
- Having provided informed written consent
Group 2 - Patients included at Viecuri hospital: additional PET-MRI and OCT
- NSTEMI or STEMI patients who underwent urgent percutaneous coronary intervention (PCI) of the culprit vessel, who are diagnosed with multivessel coronary disease and are currently scheduled for a second PCI at the VieCuri hospital
- Currently stable and scheduled for another PCI at the VieCuri hospital to stent another coronary vessel
- Able to visit the MUMC by own transport / train for PET-MR imaging before the new PCI procedure
- Minimum age of 18 years
- Mentally competent
- Having provided informed written consent
Group 3 - Patients included at MUMC+: additional PET-MRI
- Recently diagnosed with NSTEMI and scheduled for a PCI at the MUMC
- GRACE risk score between 90 and 140
- Acute Coronary Syndrome (ACS) type 1
- Minimum age of 18 years
- Mentally competent
- Having provided informed written consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6229HX
About this study
Official title: Molecular Imaging of Coronary Plaque Vulnerability Using 18F-fluorocholine PET-MRI in Patients With Coronary Artery Disease
This study is designed as a prospective observational feasibility study. The investigators will study whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques and whether the culprit plaque shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques. First, 15 NSTEMI or STEMI patients who underwent urgent percutaneous coronary intervention (PCI) of the culprit vessel, who are diagnosed with multivessel coronary disease and are currently scheduled for a second PCI at the VieCuri hospital will be included. These patients will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+ and an additional optical coherence tomography (OCT) examination (during the PCI procedure at the Viecuri hospital). OCT will be performed as a reference standard to validate 18F-choline PET-MRI for detection of vulnerable plaques in the coronary arteries. In addition, 15 NSTEMI patients, who are scheduled for PCI of the culprit lesion at the MUMC+, will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+. Hereby, the culprit coronary vessel and thereby the culprit plaque can be identified by the location of the myocardial infarct, as identified by late enhanced MRI. The investigators will study whether the culprit plaque shows an increased 18F-choline uptake on 18F-choline PET-MRI compared to non-culprit plaques in the other coronary arteries. All patients will receive standard, guideline-based clinical care, while PET-MRI and OCT will be performed as additional measurements. Before the start of the study, 5 stable angina pectoris patients that are scheduled for a PCI procedure at the MUMC+ will be included at the MUMC+ for a single PET-MRI scan to optimize the parameters of the coronary PET-MRI scan.
Read the detailed description
Background of the study:
Myocardial infarction (MI) frequently recurs after MI, which may be related to insufficient vulnerable plaque identification using invasive coronary angiography. More accurate identification of vulnerable plaques may improve therapeutic strategies and clinical outcome. Recently, the investigators demonstrated that 18F-choline PET can be used to identify vulnerable carotid plaques. The investigators hypothesize that fully integrated 18F-choline PET-MRI enables detection of vulnerable coronary plaques.
Objective of the study:
The objective is to study the feasibility to detect vulnerable coronary plaques with 18F-choline PET-MRI.
Primary study parameters/outcome of the study:
- To investigate whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques.
- To investigate whether the culprit plaque shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques.
Secondary study parameters/outcome of the study (if applicable):
- To study whether there is a correlation between the uptake of 18F-choline in coronary plaques and the degree of stenosis as shown on the angiogram acquired during the PCI procedure
- To study whether there is a correlation between the uptake of 18F-choline in coronary plaques and the presence of macrophages, micro-calcifications, lipid-rich necrotic core on OCT
- To investigate whether there is an association between the uptake of 18F-choline in the coronary arteries and that in the carotid arteries.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
This study will not delay any necessary treatment and the study is not expected to adversely affect outcome. The patients from the VieCuri will need to visit the MUMC for the additional PET-MRI scan. All patients in this study, including the 5 patients for protocol optimisation, will receive an average radiation dose of 5.3 mSv (0.019 mSv/MBq [see attachment 1], 280 MBq, average body weight 70 kg) and a maximum radiation dose of 6.8 mSv (360 MBq, ≥ 90 kg body weight) from the 18F-choline tracer. PET-MRI, Gadolinium and 18F-choline are safe and the risk of adverse effects are low (as described in chapter 7). The additional OCT examination is performed during the PCI procedure (only in the 15 patients of the VieCuri hospital), that is part of standard patient care, and carries the same risks as the PCI procedure, including: coronary dissection, air embolism, coronary thrombus, contrast nephropathy, contrast allergy, cardiovascular event, and death (extremely rare). These risks will be minimized by the use of heparin to achieve an Activating Clotting Time (ACT) value of 300, taking care of meticulous positioning of the wire and using the OCT catheter under fluoroscopy guidance. Approximately 15% of the amount of contrast agent that is used during an PCI procedure will be additionally administered during the OCT procedure and 30 seconds of additional fluoroscopy guidance with associated increase in ionizing radiation dose will be used for positioning of the OCT catheter. During the additional PET- MRI and OCT examinations, there is a chance on accidental medical findings. These findings will be reported to the treating physician and the general practitioner of the patient. Study results are expected to contribute to improvement of vulnerable plaque detection for future patients.
- Conditions
- Myocardial Infarction, Myocardial Ischemia, Atherosclerosis, Coronary Artery Disease, Coronary Stenosis, Heart Attack
- Being tested
- PET-MRI, Optical Coherence Tomography
- Medical subject headings
- Myocardial Infarction, Myocardial Ischemia, Atherosclerosis, Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRIDiagnostic test
Additional 18F-choline PET-MRI examination
Optical Coherence TomographyProcedure or surgery
Additional optical coherence tomography (OCT) examination (during the already planned routine PCI procedure)
| Study group | Role | What they receive |
|---|---|---|
| Optimization subjects | Before the enrollment of the actual study subjects, 5 stable angina pectoris patients that are scheduled for a PCI procedure at the MUMC+ will be included at the MUMC+ for a single PET-MRI scan to optimize the parameters of the coronary PET-MRI scan. All patients will receive standard, guideline-based clinical care, while PET-MRI will be performed as an additional measurement. Receives: Diagnostic Test: PET-MRI | |
| Patients from the VieCuri hospital | 15 NSTEMI or STEMI patients who underwent urgent percutaneous coronary intervention (PCI) of the culprit vessel, who are diagnosed with multivessel coronary disease and are currently scheduled for a second PCI at the VieCuri hospital will be included. These patients will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+ and an additional optical coherence tomography (OCT) examination (during the PCI procedure) at the Viecuri hospital. OCT will be performed as a reference standard to validate 18F-choline PET-MRI for detection of vulnerable plaques in the coronary arteries. All patients will receive standard, guideline-based clinical care, while PET-MRI and OCT will be performed as additional measurements. Receives: Diagnostic Test: PET-MRI; Procedure: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques.
Measured: 72 hours
To investigate whether the culprit plaque shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques.
Measured: 72 hours
Secondary outcomes (3)
To study whether there is a correlation between the uptake of 18F-choline in coronary plaques and the degree of stenosis as shown on the angiogram acquired during the PCI procedure
Measured: 72 hours
To study whether there is a correlation between the uptake of 18F-choline in coronary plaques and the presence of macrophages, micro-calcifications, lipid-rich necrotic core on OCT
Measured: 72 hours
To investigate whether there is an association between the uptake of 18F-choline in the coronary arteries and that in the carotid arteries.
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start2 Mar 2018
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VieCuri Medical Centre, Stichting de Weijerhorst
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252990
- Sponsor's protocol ID
- NL58752.068.16
- Status last verified
- Feb 2020
- First submitted
- 14 Aug 2017
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of Coronary Plaque Vulnerability Using 18F-fluorocholine PET-MRI in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03252990
- Acronym / sponsor ID
- NL58752.068.16
- Conditions
- Myocardial Infarction, Myocardial Ischemia, Atherosclerosis, Coronary Artery Disease, Coronary Stenosis, Heart Attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- VieCuri Medical Centre, Stichting de Weijerhorst
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 17 Aug 2017 (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 is designed as a prospective observational feasibility study. The investigators will study whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques and whether the culprit plaque shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques. First, 15 NSTEMI or STEMI patients who underwent urgent percutaneous coronary intervention (PCI) of the culprit vessel, who are diagnosed with multivessel coronary disease and are currently scheduled for a second PCI at the VieCuri hospital will be included. These patients will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+ and an additional optical coherence tomography (OCT) examination (during the PCI procedure at the Viecuri hospital). OCT will be performed as a reference standard to validate 18F-choline PET-MRI for detection of vulnerable plaques in the coronary arteries. In addition, 15 NSTEMI patients, who are scheduled for PCI of the culprit lesion at the MUMC+, will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+. Hereby, the culprit coronary vessel and thereby the culprit plaque can be identified by the location of the myocardial infarct, as identified by late enhanced MRI. The investigators will study whether the culprit plaque shows an increased 18F-choline uptake on 18F-choline PET-MRI compared to non-culprit plaques in the other coronary arteries. All patients will receive standard, guideline-based clinical care, while PET-MRI and OCT will be performed as additional measurements. Before the start of the study, 5 stable angina pectoris patients that are scheduled for a PCI procedure at the MUMC+ will be included at the MUMC+ for a single PET-MRI scan to optimize the parameters of the coronary PET-MRI scan.
Detailed description
Background of the study:
Myocardial infarction (MI) frequently recurs after MI, which may be related to insufficient vulnerable plaque identification using invasive coronary angiography. More accurate identification of vulnerable plaques may improve therapeutic strategies and clinical outcome. Recently, the investigators demonstrated that 18F-choline PET can be used to identify vulnerable carotid plaques. The investigators hypothesize that fully integrated 18F-choline PET-MRI enables detection of vulnerable coronary plaques.
Objective of the study:
The objective is to study the feasibility to detect vulnerable coronary plaques with 18F-choline PET-MRI.
Primary study parameters/outcome of the study:
- To investigate whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques.
- To investigate whether the culprit plaque shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques.
Secondary study parameters/outcome of the study (if applicable):
- To study whether there is a correlation between the uptake of 18F-choline in coronary plaques and the degree of stenosis as shown on the angiogram acquired during the PCI procedure
- To study whether there is a correlation between the uptake of 18F-choline in coronary plaques and the presence of macrophages, micro-calcifications, lipid-rich necrotic core on OCT
- To investigate whether there is an association between the uptake of 18F-choline in the coronary arteries and that in the carotid arteries.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
This study will not delay any necessary treatment and the study is not expected to adversely affect outcome. The patients from the VieCuri will need to visit the MUMC for the additional PET-MRI scan. All patients in this study, including the 5 patients for protocol optimisation, will receive an average radiation dose of 5.3 mSv (0.019 mSv/MBq [see attachment 1], 280 MBq, average body weight 70 kg) and a maximum radiation dose of 6.8 mSv (360 MBq, ≥ 90 kg body weight) from the 18F-choline tracer. PET-MRI, Gadolinium and 18F-choline are safe and the risk of adverse effects are low (as described in chapter 7). The additional OCT examination is performed during the PCI procedure (only in the 15 patients of the VieCuri hospital), that is part of standard patient care, and carries the same risks as the PCI procedure, including: coronary dissection, air embolism, coronary thrombus, contrast nephropathy, contrast allergy, cardiovascular event, and death (extremely rare). These risks will be minimized by the use of heparin to achieve an Activating Clotting Time (ACT) value of 300, taking care of meticulous positioning of the wire and using the OCT catheter under fluoroscopy guidance. Approximately 15% of the amount of contrast agent that is used during an PCI procedure will be additionally administered during the OCT procedure and 30 seconds of additional fluoroscopy guidance with associated increase in ionizing radiation dose will be used for positioning of the OCT catheter. During the additional PET- MRI and OCT examinations, there is a chance on accidental medical findings. These findings will be reported to the treating physician and the general practitioner of the patient. Study results are expected to contribute to improvement of vulnerable plaque detection for future patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimization subjects | – | Diagnostic Test: PET-MRIBefore the enrollment of the actual study subjects, 5 stable angina pectoris patients that are scheduled for a PCI procedure at the MUMC+ will be included at the MUMC+ for a single PET-MRI scan to optimize the parameters of the coronary PET-MRI scan. All patients will receive standard, guideline-based clinical care, while PET-MRI will be performed as an additional measurement. |
| Patients from the VieCuri hospital | – | Diagnostic Test: PET-MRI, Procedure: Optical Coherence Tomography15 NSTEMI or STEMI patients who underwent urgent percutaneous coronary intervention (PCI) of the culprit vessel, who are diagnosed with multivessel coronary disease and are currently scheduled for a second PCI at the VieCuri hospital will be included. These patients will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+ and an additional optical coherence tomography (OCT) examination (during the PCI procedure) at the Viecuri hospital. OCT will be performed as a reference standard to validate 18F-choline PET-MRI for detection of vulnerable plaques in the coronary arteries. All patients will receive standard, guideline-based clinical care, while PET-MRI and OCT will be performed as additional measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- See 'Group descriptions'
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-MRIAdditional 18F-choline PET-MRI examination | Diagnostic test | Optimization subjects, Patients from the VieCuri hospital |
| Optical Coherence TomographyAdditional optical coherence tomography (OCT) examination (during the already planned routine PCI procedure) | Procedure or surgery | Patients from the VieCuri hospital |
Primary outcome
To investigate whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques.
Time frame: 72 hours
To investigate whether the culprit plaque shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques.
Time frame: 72 hours
3 secondary outcomes
To study whether there is a correlation between the uptake of 18F-choline in coronary plaques and the degree of stenosis as shown on the angiogram acquired during the PCI procedure
Time frame: 72 hours
To study whether there is a correlation between the uptake of 18F-choline in coronary plaques and the presence of macrophages, micro-calcifications, lipid-rich necrotic core on OCT
Time frame: 72 hours
To investigate whether there is an association between the uptake of 18F-choline in the coronary arteries and that in the carotid arteries.
Time frame: 1.5 hours
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 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myocardial Infarction and Myocardial Ischemia, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Feb 2020. 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 Netherlands. 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?
To investigate whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques. (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.