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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

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

Condition or disease Intervention/treatment Phase
Coronary Artery Diseases Other: 18-F Sodium Fluoride Uptake in Positron emission tomography Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
Study Start Date : August 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
stable angina pectoris or acute coronary syndrome Other: 18-F Sodium Fluoride Uptake in Positron emission tomography



Primary Outcome Measures :
  1. Standardized 18F-NaF uptake value within the culprit plaque [ Time Frame: At the time of diagnosis ]

Secondary Outcome Measures :
  1. The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography [ Time Frame: at the time of diagnosis ]
  2. The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography [ Time Frame: at the time of diagnosis ]
  3. The relationship between 18F-NaF uptake value and biomarkers [ Time Frame: at the time of diagnosis ]
    hs-CRP, Troponin-I

  4. The relationship between 18F-NaF uptake value and invasive imagings [ Time Frame: at the time of diagnosis ]
    Intravascular ultrasound, Optical coherence tomography



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665248


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CHEOL WHAN LEE, MD, PhD.
Investigators
Principal Investigator: Cheol Whan Lee, MD, PhD Asan Medical Center

Responsible Party: CHEOL WHAN LEE, MD, PhD., MD, PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01665248     History of Changes
Other Study ID Numbers: AMCCV2012-03
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea:
18-F Sodium Fluoride
Acute coronary syndrome
Stable Angina

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents