Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation

NCT ID: NCT00114504

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-04-30

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.

Conditions

Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simvastatin group

Patients with FDG-positive plaque who received simvastatin and diet therapy

Group Type: EXPERIMENTAL

simvastatin

Intervention Type: DRUG

simvastatin 5-10 mg/day

Control group

Patients FDG-positive plaque who received diet therapy alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

simvastatin

simvastatin 5-10 mg/day

Intervention Type: DRUG

Other Intervention Names

control

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kurume University

OTHER

Sponsor Role: lead

Responsible Party

Hisashi Kai

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hisashi Kai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Third Department of Internal Medicine, Kurume University

Locations

Kurume University Hospital

Kurume, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 17418291 (View on PubMed)

Other Identifiers

KurumeU-2416

Identifier Type: -

Identifier Source: org_study_id