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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisashi Kai, Kurume University
ClinicalTrials.gov Identifier:
NCT00114504
First received: June 15, 2005
Last updated: May 13, 2015
Last verified: May 2015
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    Change in plaque inflammation was assessed by changes in the plaque SUV.


Secondary Outcome Measures:
  • Circulating Inflammation Marker [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Kurume University

Additional 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
Study First Received: June 15, 2005
Results First Received: March 31, 2015
Last Updated: May 13, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on July 30, 2015