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

Primary Purpose

Coronary Artery Diseases

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
18-F Sodium Fluoride Uptake in Positron emission tomography
Sponsored by
CHEOL WHAN LEE, MD, PhD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Diseases focused on measuring 18-F Sodium Fluoride, Acute coronary syndrome, Stable Angina

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

stable angina pectoris or acute coronary syndrome

Arm Description

Outcomes

Primary Outcome Measures

Standardized 18F-NaF uptake value within the culprit plaque

Secondary Outcome Measures

The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography
The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography
The relationship between 18F-NaF uptake value and biomarkers
hs-CRP, Troponin-I
The relationship between 18F-NaF uptake value and invasive imagings
Intravascular ultrasound, Optical coherence tomography

Full Information

First Posted
August 13, 2012
Last Updated
July 25, 2014
Sponsor
CHEOL WHAN LEE, MD, PhD.
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1. Study Identification

Unique Protocol Identification Number
NCT01665248
Brief Title
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
Official Title
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHEOL WHAN LEE, MD, PhD.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Diseases
Keywords
18-F Sodium Fluoride, Acute coronary syndrome, Stable Angina

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stable angina pectoris or acute coronary syndrome
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
18-F Sodium Fluoride Uptake in Positron emission tomography
Primary Outcome Measure Information:
Title
Standardized 18F-NaF uptake value within the culprit plaque
Time Frame
At the time of diagnosis
Secondary Outcome Measure Information:
Title
The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography
Time Frame
at the time of diagnosis
Title
The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography
Time Frame
at the time of diagnosis
Title
The relationship between 18F-NaF uptake value and biomarkers
Description
hs-CRP, Troponin-I
Time Frame
at the time of diagnosis
Title
The relationship between 18F-NaF uptake value and invasive imagings
Description
Intravascular ultrasound, Optical coherence tomography
Time Frame
at the time of diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol Whan Lee, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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