Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
This study has been terminated.
Sponsor:
CHEOL WHAN LEE, MD, PhD.
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: July 25, 2014
Last verified: July 2014
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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:
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
| 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| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01665248
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | August 13, 2012 |
| Last Updated: | July 25, 2014 |
| 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:
|
Syndrome Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Angina, Stable Disease Pathologic Processes 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 |
ClinicalTrials.gov processed this record on September 27, 2016