Comparison of 18F-fluorodeoxyglucose Positron Emission To... | NCT01100671

Studies
Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation

NCT01100671

Sponsor

Korea University

Status

Completed

Last Update Posted

Mar 14, 2018Actual

Enrollment

120Actual

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

Mar 2018

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

Apr 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Apr 8, 2010

First Submission Date that Met QC Criteria

Apr 8, 2010

First Posted Date

Apr 9, 2010Estimated

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

Mar 12, 2018

Last Update Posted Date

Mar 14, 2018Actual

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. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium (CAC), the degree of stenosis, and the characteristics of plaque including its potential vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.

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

120Actual

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 of vascular inflammation assessed by 18FDG-PET and MDCT at the cross section setting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between vascular inflammatory status measured by 18FDG PET and MDCT		20weeks

Secondary Outcomes

Measure	Description	Time Frame
Comparison the correlation with inflammatory marker and vascular inflammatory status assessed by 18FDG PET and MDCT		20 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

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy participants 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
26892510	Derived	Yoo HJ, Yong HS, Hwang SY, Eo JS, Hong HC, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Association of pooled cohort risk scores with vascular inflammation and coronary artery calcification in Korean adults. Metabolism. 2016 Mar;65(3):1-7. doi: 10.1016/j.metabol.2015.10.016. Epub 2015 Oct 22.

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