Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03252990
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2017-08-14
Brief Title:
18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Molecular Imaging of Coronary Plaque Vulnerability Using 18F-fluorocholine PET-MRI in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 parametersoutcome 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 parametersoutcome 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 53 mSv 0019 mSvMBq see attachment 1 280 MBq average body weight 70 kg and a maximum radiation dose of 68 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
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 parametersoutcome 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 parametersoutcome 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 53 mSv 0019 mSvMBq see attachment 1 280 MBq average body weight 70 kg and a maximum radiation dose of 68 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None