- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01665248
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
July 25, 2014 updated by: CHEOL WHAN LEE, MD, PhD.
The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: stable angina pectoris or acute coronary syndrome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Standardized 18F-NaF uptake value within the culprit plaque
Time Frame: At the time of diagnosis
|
At the time of diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography
Time Frame: at the time of diagnosis
|
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
|
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
|
at the time of diagnosis
|
The relationship between 18F-NaF uptake value and invasive imagings
Time Frame: at the time of diagnosis
|
Intravascular ultrasound, Optical coherence tomography
|
at the time of diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cheol Whan Lee, MD, PhD, Asan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
August 13, 2012
First Submitted That Met QC Criteria
August 13, 2012
First Posted (Estimate)
August 15, 2012
Study Record Updates
Last Update Posted (Estimate)
July 28, 2014
Last Update Submitted That Met QC Criteria
July 25, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Coronary Disease
- Chest Pain
- Angina Pectoris
- Coronary Artery Disease
- Acute Coronary Syndrome
- Angina, Stable
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Protective Agents
- Cariostatic Agents
- Listerine
- Fluorides
- Sodium Fluoride
Other Study ID Numbers
- AMCCV2012-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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