Overview

This trial is active, not recruiting.

Condition atherosclerosis
Treatment statins (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, or rosuvastatin)
Sponsor Kurume University
Start date September 2004
End date April 2007
Trial size 1000 participants
Trial identifier NCT00114504, KurumeU-2416

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Patients with FDG-positive plaque.
(No Intervention)
Patients with plaque but not with FDG uptake.
(Active Comparator)
Patients with FDG-positive plaque receiving statin therapy.
statins (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, or rosuvastatin)
pravastatin 10-20 mg/day, simvastatin 5-10 mg/day, fluvastatin 20-60 mg/day, atorvastatin 10-40 mg/day, pitavastatin 1-4 mg/day, or rosuvastatin 2.5-20 mg/day
(No Intervention)
Patients with FDG-positive plaque receiving diet management therapy.

Primary Outcomes

Measure
attenuation of plaque inflammation (decrease in plaque SUV) at 3 and 12 months; cardiovascular events at 1 and 3 years
time frame: 3 years

Secondary Outcomes

Measure
attenuation of circulating inflammation markers at 3 and 12 months
time frame: 1 year
all cause death at 1 and 3 years; changes in carotid plaque index and plaque thickness
time frame: 3 years

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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

Additional Information

Official title Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-Inflammatory Effects of Statins on Plaque Inflammation by FDG-PET
Principal investigator Hisashi Kai, MD, PhD
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. Comparisons: Patients with FDG-positive plaque, compared to patients with plaque but not with FDG uptake. Patients with FDG-positive plaque receiving statin therapy, compared to patients with FDG-positive plaque receiving diet management therapy.
Trial information was received from ClinicalTrials.gov and was last updated in November 2008.
Information provided to ClinicalTrials.gov by Kurume University.