Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01665248 |
Recruitment Status :
Terminated
First Posted : August 15, 2012
Last Update Posted : July 28, 2014
|
Sponsor:
CHEOL WHAN LEE, MD, PhD.
Information provided by (Responsible Party):
CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | August 13, 2012 | |||
First Posted Date ICMJE | August 15, 2012 | |||
Last Update Posted Date | July 28, 2014 | |||
Study Start Date ICMJE | August 2012 | |||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Standardized 18F-NaF uptake value within the culprit plaque [ Time Frame: At the time of diagnosis ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina | |||
Official Title ICMJE | Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina | |||
Brief Summary | The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
|||
Condition ICMJE | Coronary Artery Diseases | |||
Intervention ICMJE | Other: 18-F Sodium Fluoride Uptake in Positron emission tomography | |||
Study Arms ICMJE | stable angina pectoris or acute coronary syndrome
Intervention: Other: 18-F Sodium Fluoride Uptake in Positron emission tomography
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Actual Study Completion Date ICMJE | May 2013 | |||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 21 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01665248 | |||
Other Study ID Numbers ICMJE | AMCCV2012-03 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea | |||
Study Sponsor ICMJE | CHEOL WHAN LEE, MD, PhD. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | CardioVascular Research Foundation, Korea | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |