18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability

NCT03252990 | Completed DMC

• 1 other identifier: NL58752.068.16
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Myocardial Ischemia; Atherosclerosis; Coronary Artery Disease; Coronary Stenosis; Heart Attack; Multi Vessel Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  72 hours

• To investigate whether the culprit plaque shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques.

  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

  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

  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.

  1.5 hours

Study Arms (2)

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.

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.

Diagnostic Test: PET-MRI; Procedure: Optical Coherence Tomography

Interventions

PET-MRI DIAGNOSTIC_TEST

Additional 18F-choline PET-MRI examination

Optimization subjects; Patients from the VieCuri hospital

Optical Coherence Tomography PROCEDURE

Additional optical coherence tomography (OCT) examination (during the already planned routine PCI procedure)

Patients from the VieCuri hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• VieCuri Medical Centre: collaborator
• Stichting de Weijerhorst: collaborator

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia; Atherosclerosis; Coronary Artery Disease; Coronary Stenosis

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: March 2, 2018
• Primary Completion: December 6, 2019
• Study Completion: December 6, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)