18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability
NCT03252990 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15
Last updated 2020-02-21
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.
Conditions
- Myocardial Infarction
- Myocardial Ischemia
- Atherosclerosis
- Coronary Artery Disease
- Coronary Stenosis
- Heart Attack
- Multi Vessel Coronary Artery Disease
Interventions
- DIAGNOSTIC_TEST
-
PET-MRI
Additional 18F-choline PET-MRI examination
- PROCEDURE
-
Optical Coherence Tomography
Additional optical coherence tomography (OCT) examination (during the already planned routine PCI procedure)
Sponsors & Collaborators
-
VieCuri Medical Centre
collaborator OTHER -
Stichting de Weijerhorst
collaborator UNKNOWN -
Maastricht University Medical Center
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-03-02
- Primary Completion
- 2019-12-06
- Completion
- 2019-12-06
Countries
- Netherlands
Study Locations
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