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

This study has been terminated.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01665248

First Posted: August 15, 2012

Last Update Posted: July 28, 2014

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.

Information provided by (Responsible Party):

CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea

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: 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

Resource links provided by NLM:

MedlinePlus related topics: Angina

Drug Information available for: Sodium fluoride Fluorine Fluoride Listerine

U.S. FDA Resources

Further study details as provided by CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	20
Study Start Date:	August 2012
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
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

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

More Information


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 Submitted:	August 13, 2012
First Posted:	August 15, 2012
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

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