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

Coronary Artery Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01665248
• Other study ID #: AMCCV2012-03
• Status: Terminated
• Phase: N/A
• First received: August 13, 2012
• Last updated: July 25, 2014
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, MD, PhD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized 18F-NaF uptake value within the culprit plaque		At the time of diagnosis	No
Secondary	The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography		at the time of diagnosis	No
Secondary	The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography		at the time of diagnosis	No
Secondary	The relationship between 18F-NaF uptake value and biomarkers	hs-CRP, Troponin-I	at the time of diagnosis	No
Secondary	The relationship between 18F-NaF uptake value and invasive imagings	Intravascular ultrasound, Optical coherence tomography	at the time of diagnosis	No