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

Purpose

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

ChemIDplus related topics:

Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-Inflammatory Effects of Statins on Plaque Inflammation by FDG-PET

Further study details as provided by Kurume University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Study Start Date:

September 2004

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.

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.

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114504

Locations


Japan
	Kurume University Hospital	Recruiting
	Kurume, Japan, 830-0011
	Contact: Hisashi Kai, MD, PhD +81-942-31-7562 naikai@med.kurume-u.ac.jp
	Contact: Nobuhiro Tahara, MD, PhD +81-942-31-7707 ntahara@med.kurume-u.ac.jp
	Principal Investigator: Hisashi Kai, MD, PhD
	Sub-Investigator: Nobuhiro Tahara, MD, PhD
	Sub-Investigator: Daisuke Fukui, MD

Sponsors and Collaborators

Kurume University

More Information

Publications indexed to this study:

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. Epub 2007 Mar 26.

Study ID Numbers:	KurumeU-2416
First Received:	June 15, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00114504
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kurume University:

atherosclerosis

inflammation

statins

PET

carotid ultrasonography

Study placed in the following topic categories:

Arterial Occlusive Diseases

Atherosclerosis

Simvastatin

Vascular Diseases

Arteriosclerosis

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Kurume University
Information provided by:	Kurume University
ClinicalTrials.gov Identifier:	NCT00114504