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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114504
First Posted: June 16, 2005
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hisashi Kai, Kurume University
  Purpose
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
Atherosclerosis Drug: simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Hisashi Kai, 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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114504


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hisashi Kai, Associate professor, Kurume University
ClinicalTrials.gov Identifier: NCT00114504     History of Changes
Other Study ID Numbers: KurumeU-2416
First Submitted: June 15, 2005
First Posted: June 16, 2005
Results First Submitted: March 31, 2015
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by Hisashi Kai, Kurume University:
atherosclerosis
inflammation
statins
PET
carotid ultrasonography

Additional relevant MeSH terms:
Inflammation
Atherosclerosis
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors