Correlation Between Various Inflammatory Markers and Vasc... | NCT01022684

Studies
Correlation Between Various Inflammatory Markers and Vascular Inflammation Measured by 18FDG-PET

NCT01022684

Sponsor

Korea University

Status

Completed

Last Update Posted

Feb 22, 2010Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Atherosclerosis

Interventions

Cross section study

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Nov 27, 2009

First Submission Date that Met QC Criteria

Nov 30, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2010

Last Update Posted Date

Feb 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. Various inflammatory markers such as LpPLA2,MCP-2 and hsCRP are well-known prognostic factors for the cardiovascular event.

18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between various inflammatory markers and vascular inflammation detected by 18FDG-PET.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy patients			Other: Cross section study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cross section study	Other	This is not intervention study. The purpose of the study is to examine the relationship between various inflammatory markers and PET imaging at the cross section setting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between various inflammatory markers including LpPLA2,MCP-1 and hsCRP and vascular inflammation analyzed by 18FDG-PET		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Correlation between various inflammatory markers and atherosclerosis measured by carotid intima media thickness		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy patients for visiting routine medical check in our clinic

Exclusion Criteria:

History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
Diabetes
Stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
Malignancy
Severe renal or hepatic disease
Subjects taking medications that might affect inflammation such as NSIAD and statin

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

88 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy participatin who underwent a medical health check in the health promotion center in Korea Guro University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung Mook Choi, MD.PhD	Korea University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hye Jin Yoo		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21719129	Derived	Yang SJ, Kim S, Choi HY, Kim TN, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. High-sensitivity C-reactive protein in the low- and intermediate-Framingham risk score groups: analysis with 18F-fluorodeoxyglucose positron emission tomography. Int J Cardiol. 2013 Mar 10;163(3):277-281. doi: 10.1016/j.ijcard.2011.06.054. Epub 2011 Jun 29.

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases