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

Atherosclerosis Clinical Trial

Official title:

Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114504
• Other study ID #: KurumeU-2416
• Status: Completed
• Phase: N/A
• First received: June 15, 2005
• Last updated: May 13, 2015
• Start date: September 2004
• Est. completion date: April 2009

Study information

• Verified date: May 2015
• Source: Kurume University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2009
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation

Intervention

Drug:
• simvastatin
simvastatin 5-10 mg/day

Locations

Country	Name	City	State
Japan	Kurume University Hospital	Kurume

Sponsors (1)

Lead Sponsor	Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Inflammation	Change in plaque inflammation was assessed by changes in the plaque SUV.	Baseline, 3 months	No
Secondary	Circulating Inflammation Marker	Change in circulating hsCRP levels	Baseline, 3 months	No