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

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
simvastatin
Sponsored by
Kurume University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring atherosclerosis, inflammation, statins, PET, carotid ultrasonography

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kurume University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Simvastatin group

Control group

Arm Description

Patients with FDG-positive plaque who received simvastatin and diet therapy

Patients FDG-positive plaque who received diet therapy alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Circulating Inflammation Marker
Change in circulating hsCRP levels

Full Information

First Posted
June 15, 2005
Last Updated
May 13, 2015
Sponsor
Kurume University
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1. Study Identification

Unique Protocol Identification Number
NCT00114504
Brief Title
Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
Official Title
Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kurume University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
atherosclerosis, inflammation, statins, PET, carotid ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin group
Arm Type
Experimental
Arm Description
Patients with FDG-positive plaque who received simvastatin and diet therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients FDG-positive plaque who received diet therapy alone
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
control
Intervention Description
simvastatin 5-10 mg/day
Primary Outcome Measure Information:
Title
Plaque Inflammation
Description
Change in plaque inflammation was assessed by changes in the plaque SUV.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Circulating Inflammation Marker
Description
Change in circulating hsCRP levels
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisashi Kai, MD, PhD
Organizational Affiliation
The Third Department of Internal Medicine, Kurume University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17418291
Citation
Tahara N, Kai H, Yamagishi S, Mizoguchi M, Nakaura H, Ishibashi M, Kaida H, Baba K, Hayabuchi N, Imaizumi T. Vascular inflammation evaluated by [18F]-fluorodeoxyglucose positron emission tomography is associated with the metabolic syndrome. J Am Coll Cardiol. 2007 Apr 10;49(14):1533-9. doi: 10.1016/j.jacc.2006.11.046. Epub 2007 Mar 26.
Results Reference
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Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation

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