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.

Condition	Intervention
Atherosclerosis	Drug: statins

Further Study Details: 

Primary Outcomes: attenuation of plaque inflammation (decrease in plaque SUV) at 3 and 12 months; cardiovascular events at 1 and 3 years
Secondary Outcomes: attenuation of circulating inflammation markers at 3 and 12 months; all cause death at 1 and 3 years; changes in carotid plaque index and plaque thickness

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.

Ages Eligible for Study:  30 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00114504

Japan
      Kurume University Hospital, Kurume,  830-0011,  Japan; Recruiting

Study ID Numbers:  KurumeU-2416
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 15, 2005
ClinicalTrials.gov Identifier:  NCT00114504
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-07-05