N/A
N=43
Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00114504 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Plaque Inflammation — 1.59; 1.63 SUV
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- simvastatin (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Kurume University
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plaque Inflammation |
1.59; 1.63 | — |
| SECONDARY Circulating Inflammation Marker |
0.09; 0.06; 0.11; 0.07 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00114504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.