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

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ClinicalTrials.gov Identifier: NCT01665248
Recruitment Status : Terminated
First Posted : August 15, 2012
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea

Tracking Information
First Submitted Date  ICMJE August 13, 2012
First Posted Date  ICMJE August 15, 2012
Last Update Posted Date July 28, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2012)
Standardized 18F-NaF uptake value within the culprit plaque [ Time Frame: At the time of diagnosis ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2012)
  • The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography [ Time Frame: at the time of diagnosis ]
  • The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography [ Time Frame: at the time of diagnosis ]
  • The relationship between 18F-NaF uptake value and biomarkers [ Time Frame: at the time of diagnosis ]
    hs-CRP, Troponin-I
  • The relationship between 18F-NaF uptake value and invasive imagings [ Time Frame: at the time of diagnosis ]
    Intravascular ultrasound, Optical coherence tomography
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
Official Title  ICMJE Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
Brief Summary The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Diseases
Intervention  ICMJE Other: 18-F Sodium Fluoride Uptake in Positron emission tomography
Study Arms  ICMJE stable angina pectoris or acute coronary syndrome
Intervention: Other: 18-F Sodium Fluoride Uptake in Positron emission tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 25, 2014)
20
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2012)
100
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01665248
Other Study ID Numbers  ICMJE AMCCV2012-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea
Study Sponsor  ICMJE CHEOL WHAN LEE, MD, PhD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheol Whan Lee, MD, PhD Asan Medical Center
PRS Account CardioVascular Research Foundation, Korea
Verification Date July 2014

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