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

Tracking Information

First Received Date ^ICMJE

June 15, 2005

Last Updated Date

November 20, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

attenuation of plaque inflammation (decrease in plaque SUV) at 3 and 12 months; cardiovascular events at 1 and 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00114504 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

attenuation of circulating inflammation markers at 3 and 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
all cause death at 1 and 3 years; changes in carotid plaque index and plaque thickness [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Atherosclerosis

Intervention ^ICMJE

Drug: statins (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, or rosuvastatin)

Study Arms / Comparison Groups

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.
No Intervention: Patients with FDG-positive plaque receiving diet management therapy.

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

April 2009

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00114504

Responsible Party

Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume Universitu

Study ID Numbers ^ICMJE

KurumeU-2416

Study Sponsor ^ICMJE

Kurume University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hisashi Kai, MD, PhD

The Third Department of Internal Medicine, Kurume University

Information Provided By

Kurume University

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP