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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
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: | 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:
|
Acute Coronary Syndrome Coronary Artery Disease Coronary Disease Myocardial Ischemia Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Heart Diseases Pain Signs and Symptoms |
Vascular Diseases Fluorides Listerine Sodium Fluoride Anti-Infective Agents Anti-Infective Agents, Local Cariostatic Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015