Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CHEOL WHAN LEE, MD, PhD.
Investigators
Layout table for investigator information
Principal Investigator: Cheol Whan Lee, MD, PhD Asan Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: CHEOL WHAN LEE, MD, PhD., MD, PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01665248    
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:
Layout table for MeSH terms
Coronary Artery Disease
Acute Coronary Syndrome
Angina, Stable
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
 Chest Pain
Pain
Neurologic Manifestations
Listerine
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents