Imaging to identify vulnerable atherosclerotic plaques

Molecular Imaging of Plaque Vulnerability Using 18F-choline PET-MRI in Carotid Artery Atherosclerosis Patients

This study is testing if a special type of imaging can help doctors find dangerous plaques in the arteries of patients with carotid artery problems before they lead to serious issues.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maastricht University Medical Center (Academic / other)
• Locations: 1 site (Maastricht)
• Trial ID: NCT02640313 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of 18F-choline PET imaging in detecting inflammation within atherosclerotic plaques, which can indicate vulnerability to rupture. The research focuses on patients with symptomatic carotid artery stenosis who are undergoing treatment. By correlating the inflammatory status observed through PET imaging with other imaging techniques, the study aims to enhance the clinical diagnosis of vulnerable plaques. The goal is to improve patient outcomes by identifying high-risk plaques before they cause serious complications.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 and older with symptomatic carotid artery stenosis scheduled for carotid endarterectomy or conservative therapy.

Not a fit: Patients with severe neurological deficits, dementia, or contraindications for MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better identification and management of patients at risk for plaque rupture, potentially reducing the incidence of strokes.

How similar studies have performed: Previous studies have shown promise in using molecular imaging techniques for assessing plaque vulnerability, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Patients known with symptomatic carotid artery stenosis (≥2 mm carotid plaque on duplex ultrasound), who are scheduled in the clinical setting to undergo a carotid endarterectomy or who are referred to conservative therapy;
* Age 18 years and older (no maximum age);
* Informed consent by signing informed consent form regarding this study.

Exclusion Criteria:

* Dementia, pregnancy, nursing mothers;
* Serious neurological deficits at symptomatic side (hemi paralysis, complete aphasia);
* Severe heart failure NYHA III-IV and severe pulmonary dysfunction dependent on oxygen supply;
* Patients with contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic splinters in the eyes, vascular clips, claustrophobia, etc.).

Where this trial is running

Maastricht

• Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)

Study contacts

• Principal investigator: Jochem van der Pol, MD — Maastricht University Medical Center
• Study coordinator: Jochem van der Pol, MD

Conditions Plaque, Atherosclerotic; 18F-fluormethylcholine; [F18] choline; [F18] fluormethylcholine