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

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: simvastatin

• Registration Number: NCT00114504
• Lead Sponsor: Kurume University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-06-15
• Study First Submitted QC: 2005-06-15
• Study First Posted: 2005-06-16
• Primary Completion: 2007-04
• Study Completion: 2009-04
• Results First Submitted: 2015-03-31
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-13
• Last Update Submitted: 2015-05-13
• Results First Posted: 2015-06-01
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin group	simvastatin	Patients with FDG-positive plaque who received simvastatin and diet therapy

Primary Outcome Measures

Name	Time	Method
Plaque Inflammation	Baseline, 3 months	Change in plaque inflammation was assessed by changes in the plaque SUV.

Secondary Outcome Measures

Name	Time	Method
Circulating Inflammation Marker	Baseline, 3 months	Change in circulating hsCRP levels

Trial Locations

Locations (1)

Kurume University Hospital; 🇯🇵 Kurume, Japan