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

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
Other: 18-F Sodium Fluoride Uptake in Positron emission tomography

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

CHEOL WHAN LEE, MD, PhD.

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

Keywords

Additional Relevant MeSH Terms

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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