Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaq... | NCT01665248

Studies
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina

NCT01665248

Sponsor

CHEOL WHAN LEE, MD, PhD.

Status

Terminated

Last Update Posted

Jul 28, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Coronary Artery Diseases

Interventions

18-F Sodium Fluoride Uptake in Positron emission tomography

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

Jul 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Aug 13, 2012

First Submission Date that Met QC Criteria

Aug 13, 2012

First Posted Date

Aug 15, 2012Estimated

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

Jul 25, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

CHEOL WHAN LEE, MD, PhD., MD, PhD, CardioVascular Research Foundation, KoreaSponsor-Investigator

Lead Sponsor

CHEOL WHAN LEE, MD, PhD.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stable angina pectoris or acute coronary syndrome	Other		Other: 18-F Sodium Fluoride Uptake in Positron emission tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18-F Sodium Fluoride Uptake in Positron emission tomography	Other		stable angina pectoris or acute coronary syndrome

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standardized 18F-NaF uptake value within the culprit plaque		At the time of diagnosis

Secondary Outcomes

Measure	Description	Time Frame
The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography		at the time of diagnosis
The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography		at the time of diagnosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age more than 20
Acute coronary syndrome or stable angina

Exclusion Criteria:

Contraindications to the use of heparin, aspirin, clopidogrel, stainless metal, contrast media
Acute ST segment elevation myocardial infarction within 12hours, heart failure, cardiac shock
Any serious medical comorbidity such that the subject's life expectancy is less than 24 months
Ejection fraction less than 30
Serum creatinine level of 1.5mg/dl and over
Vasculitis
Unwillingness or inability to cooperate or to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cheol Whan Lee, MD, PhD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D054058	Acute Coronary Syndrome
D060050	Angina, Stable

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided