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

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

Tracking Information

• First Submitted Date: August 13, 2012
• First Posted Date: August 15, 2012
• Last Update Posted Date: July 28, 2014
• Study Start Date: August 2012
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 24, 2012): Standardized 18F-NaF uptake value within the culprit plaque [ Time Frame: At the time of diagnosis ]
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Coronary Artery Diseases
• Intervention: Other: 18-F Sodium Fluoride Uptake in Positron emission tomography

Study Arms

stable angina pectoris or acute coronary syndrome

Intervention: Other: 18-F Sodium Fluoride Uptake in Positron emission tomography

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 25, 2014): 20
• Original Estimated Enrollment (submitted: August 13, 2012): 100
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01665248
• Other Study ID Numbers: AMCCV2012-03
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea
• Study Sponsor: CHEOL WHAN LEE, MD, PhD.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Cheol Whan Lee, MD, PhD; Asan Medical Center

• PRS Account: CardioVascular Research Foundation, Korea
• Verification Date: July 2014