Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 15, 2005
CompletedFirst Posted
Study publicly available on registry
June 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
June 1, 2015
CompletedJune 1, 2015
May 1, 2015
2.6 years
June 15, 2005
March 31, 2015
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plaque Inflammation
Change in plaque inflammation was assessed by changes in the plaque SUV.
Baseline, 3 months
Secondary Outcomes (1)
Circulating Inflammation Marker
Baseline, 3 months
Study Arms (2)
Simvastatin group
EXPERIMENTALPatients with FDG-positive plaque who received simvastatin and diet therapy
Control group
NO INTERVENTIONPatients FDG-positive plaque who received diet therapy alone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kurume University Hospital
Kurume, 830-0011, Japan
Related Publications (1)
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.
PMID: 17418291DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hisashi Kai
- Organization
- Kurume University
Study Officials
- PRINCIPAL INVESTIGATOR
Hisashi Kai, MD, PhD
The Third Department of Internal Medicine, Kurume University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 15, 2005
First Posted
June 16, 2005
Study Start
September 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2009
Last Updated
June 1, 2015
Results First Posted
June 1, 2015
Record last verified: 2015-05