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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
  Purpose

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


Condition Intervention
Coronary Artery Diseases
 Other: 18-F Sodium Fluoride Uptake in Positron emission tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Standardized 18F-NaF uptake value within the culprit plaque [ Time Frame: At the time of diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
stable angina pectoris or acute coronary syndrome Other: 18-F Sodium Fluoride Uptake in Positron emission tomography

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665248

Contacts
Contact: Seung-Jung Park, MD, PhD 82-2-3010-4812 sjpark@amc.seoul.kr

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

No publications provided

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
Study First Received: August 13, 2012
Last Updated: August 24, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by 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
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
 Chest Pain
Pain
Signs and Symptoms
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013