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

This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Information provided by (Responsible Party):
CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01665248
First received: August 13, 2012
Last updated: August 24, 2012
Last verified: August 2012
History of Changes

August 13, 2012
August 24, 2012
August 2012
June 2014   (final data collection date for primary outcome measure)
Standardized 18F-NaF uptake value within the culprit plaque [ Time Frame: At the time of diagnosis ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01665248 on ClinicalTrials.gov Archive Site
  • The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography [ Time Frame: at the time of diagnosis ] [ Designated as safety issue: No ]
  • The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography [ Time Frame: at the time of diagnosis ] [ Designated as safety issue: No ]
  • The relationship between 18F-NaF uptake value and biomarkers [ Time Frame: at the time of diagnosis ] [ Designated as safety issue: No ]
    hs-CRP, Troponin-I
  • The relationship between 18F-NaF uptake value and invasive imagings [ Time Frame: at the time of diagnosis ] [ Designated as safety issue: No ]
    Intravascular ultrasound, Optical coherence tomography
Not Provided
Not Provided
Not Provided
 
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina

The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Diseases
Other: 18-F Sodium Fluoride Uptake in Positron emission tomography
stable angina pectoris or acute coronary syndrome
Intervention: Other: 18-F Sodium Fluoride Uptake in Positron emission tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2015
June 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Seung-Jung Park, MD, PhD 82-2-3010-4812 sjpark@amc.seoul.kr
Korea, Republic of
 
NCT01665248
AMCCV2012-03
No
CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea
CHEOL WHAN LEE, MD, PhD.
Not Provided
Principal Investigator: Cheol Whan Lee, MD, PhD Asan Medical Center
CardioVascular Research Foundation, Korea
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP