Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation

Kurume University

Status: Completed

Conditions: Atherosclerosis

Treatments: Drug: simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00114504

KurumeU-2416

Details and patient eligibility

About

The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. The usefulness of FDG-PET in risk stratification is also investigated.

Full description

There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. However, currently, no non-invasive method is available for detecting plaque inflammation in clinical practice. FDG-PET can visualize activated metabolic levels of not only tumor cells but also inflammatory cells. Thus, it is possible that FDG-PET can detect atherosclerotic plaque inflammation and that, if so, FDG-PET can monitor the direct effect of statins on plaque inflammation. Additionally, monitoring the plaque inflammation by FDG-PET may be useful for determining the risk stratification of atherosclerotic patients.

Originally, we sought to compare patients with FDG-positive plaque with patients with plaque but not with FDG uptake, patients with FDG-positive plaque receiving statin therapy, and patients with FDG-positive plaque receiving diet management therapy. However, because patient number enrolled in the study was too small, the comparison was performed between FDG-positive patients with and without any statin therapy.

Enrollment: 43 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Protocol 1: patients who had carotid atherosclerosis detected by carotid ultrasound.
• Protocol 2: patients who underwent FDG-PET for cancer screening and had vascular FDG uptakes

Exclusion criteria

• Active inflammatory diseases
• Dyslipidemia under medications
• Uncontrolled diabetes mellitus, vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases
• Known systemic disorders such as hepatic, renal, hematopoietic, and malignant diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Simvastatin group

Experimental group

Description:

Patients with FDG-positive plaque who received simvastatin and diet therapy

Treatment:

Drug: simvastatin

Control group

No Intervention group

Description:

Patients FDG-positive plaque who received diet therapy alone