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Completed

NCT Number: NCT00114504

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

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.

Completed

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kurume University Hospital

Kurume, 830-0011, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

simvastatin 5-10 mg/day

Other names: control

Primary outcomes

  1. Plaque Inflammation

    Time frame: Baseline, 3 months

    Change in plaque inflammation was assessed by changes in the plaque SUV.

Secondary outcomes

  1. Circulating Inflammation Marker

    Time frame: Baseline, 3 months

    Change in circulating hsCRP levels

Sponsors and collaborators

Lead sponsor

Kurume University

Other

Registry information

Official study title

Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Jun 16, 2005
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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