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

This study has been completed.
Information provided by (Responsible Party):
Hisashi Kai, Kurume University Identifier:
First received: June 15, 2005
Last updated: May 13, 2015
Last verified: May 2015
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.

Condition Intervention
Drug: simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET

Resource links provided by NLM:

Further study details as provided by Kurume University:

Primary Outcome Measures:
  • Plaque Inflammation [ Time Frame: Baseline, 3 months ]
    Change in plaque inflammation was assessed by changes in the plaque SUV.

Secondary Outcome Measures:
  • Circulating Inflammation Marker [ Time Frame: Baseline, 3 months ]
    Change in circulating hsCRP levels

Enrollment: 43
Study Start Date: September 2004
Study Completion Date: April 2009
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin group
Patients with FDG-positive plaque who received simvastatin and diet therapy
Drug: simvastatin
simvastatin 5-10 mg/day
Other Name: control
No Intervention: Control group
Patients FDG-positive plaque who received diet therapy alone

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.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00114504

Kurume University Hospital
Kurume, Japan, 830-0011
Sponsors and Collaborators
Kurume University
Principal Investigator: Hisashi Kai, MD, PhD The Third Department of Internal Medicine, Kurume University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hisashi Kai, Associate professor, Kurume University Identifier: NCT00114504     History of Changes
Other Study ID Numbers: KurumeU-2416
Study First Received: June 15, 2005
Results First Received: March 31, 2015
Last Updated: May 13, 2015

Keywords provided by Kurume University:
carotid ultrasonography

Additional relevant MeSH terms:
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on March 27, 2017