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

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

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 (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, or rosuvastatin)

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

Resource links provided by NLM:

MedlinePlus related topics: Statins

Drug Information available for: Simvastatin Pravastatin Pravastatin sodium Fluvastatin Atorvastatin Atorvastatin calcium Rosuvastatin calcium Pitavastatin NK 104 Rosuvastatin

U.S. FDA Resources

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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1000
Study Start Date:	September 2004
Estimated Study Completion Date:	April 2009
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1-1: No Intervention Patients with FDG-positive plaque.
1-2: No Intervention Patients with plaque but not with FDG uptake.
2-1: Active Comparator Patients with FDG-positive plaque receiving statin therapy.	Drug: statins (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, or rosuvastatin) pravastatin 10-20 mg/day, simvastatin 5-10 mg/day, fluvastatin 20-60 mg/day, atorvastatin 10-40 mg/day, pitavastatin 1-4 mg/day, or rosuvastatin 2.5-20 mg/day
2-2: No Intervention Patients with FDG-positive plaque receiving diet management therapy.

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
Kurume, Japan, 830-0011

Sponsors and Collaborators

Kurume University

Investigators

Principal Investigator:

Hisashi Kai, MD, PhD

The Third Department of Internal Medicine, Kurume University

More Information

No publications provided by Kurume University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Department of Internal Medicine, Kurume Universitu ( Division of Cardiovascular Medicine )
Study ID Numbers:	KurumeU-2416
Study First Received:	June 15, 2005
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00114504 History of Changes
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:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Simvastatin
Antilipemic Agents
Vascular Diseases
Anticholesteremic Agents
Arteriosclerosis

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Fluvastatin
Inflammation
Pravastatin
Rosuvastatin
NK 104
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Fluvastatin
Inflammation
Pravastatin
Pathologic Processes
Rosuvastatin
NK 104
Therapeutic Uses
Cardiovascular Diseases
Atorvastatin

ClinicalTrials.gov processed this record on July 06, 2009