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

• Sponsor: CHEOL WHAN LEE, MD, PhD. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01665248
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Aug 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Standardized 18F-NaF uptake value within the culprit plaque [At the time of diagnosis]

Secondary Outcome Measures

1. The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography [at the time of diagnosis]

2. The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography [at the time of diagnosis]

3. The relationship between 18F-NaF uptake value and biomarkers [at the time of diagnosis]

   hs-CRP, Troponin-I

4. The relationship between 18F-NaF uptake value and invasive imagings [at the time of diagnosis]

   Intravascular ultrasound, Optical coherence tomography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Aug 15, 2012
• Last Update Posted: Jul 28, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by CHEOL WHAN LEE, MD, PhD., MD, PhD, CardioVascular Research Foundation, Korea: 18-F Sodium Fluoride; Acute coronary syndrome; Stable Angina
• Additional relevant MeSH terms: Coronary Artery Disease; Acute Coronary Syndrome; Angina, Stable; Listerine; Fluorides; Sodium Fluoride

Study Results

No Results Posted as of Jul 28, 2014