Atherosclerosis
Conditions
Keywords
atherosclerosis, inflammation, statins, PET, carotid ultrasonography
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.
Interventions
DRUGsimvastatin
simvastatin 5-10 mg/day
Sponsors
Kurume University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Inflammation | Baseline, 3 months | Change in plaque inflammation was assessed by changes in the plaque SUV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulating Inflammation Marker | Baseline, 3 months | Change in circulating hsCRP levels |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Simvastatin Group Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy | 21 |
| Control Group Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone | 22 |
| Total | 43 |
Baseline characteristics
| Characteristic | Simvastatin Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 9 | 62 years STANDARD_DEVIATION 6 | 63 years STANDARD_DEVIATION 8 |
| Race/Ethnicity, Customized Japanese | 21 participants | 22 participants | 43 participants |
| Race/Ethnicity, Customized No Japanese | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Japan | 21 participants | 22 participants | 43 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
Primary
Plaque Inflammation
Change in plaque inflammation was assessed by changes in the plaque SUV.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simvastatin Group | Plaque Inflammation | 1.59 SUV | Standard Deviation 0.22 |
| Control Group | Plaque Inflammation | 1.63 SUV | Standard Deviation 0.12 |
Secondary
Circulating Inflammation Marker
Change in circulating hsCRP levels
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simvastatin Group | Circulating Inflammation Marker | 0.09 mg/dL | Standard Deviation 0.11 |
| Control Group | Circulating Inflammation Marker | 0.06 mg/dL | Standard Deviation 0.07 |
| Control Group Baseline | Circulating Inflammation Marker | 0.11 mg/dL | Standard Deviation 0.16 |
| Control Group at 3 Months | Circulating Inflammation Marker | 0.07 mg/dL | Standard Deviation 0.06 |