NCT01665248

Brief Summary

The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

August 13, 2012

Last Update Submit

July 25, 2014

Conditions

Coronary Artery Diseases

Keywords

18-F Sodium FluorideAcute coronary syndromeStable Angina

Outcome Measures

Primary Outcomes (1)

  • Standardized 18F-NaF uptake value within the culprit plaque

    At the time of diagnosis

Secondary Outcomes (4)

  • The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography

    at the time of diagnosis

  • The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography

    at the time of diagnosis

  • The relationship between 18F-NaF uptake value and biomarkers

    at the time of diagnosis

  • The relationship between 18F-NaF uptake value and invasive imagings

    at the time of diagnosis

Study Arms (1)

stable angina pectoris or acute coronary syndrome

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

Interventions

18-F Sodium Fluoride Uptake in Positron emission tomographyOTHER
stable angina pectoris or acute coronary syndrome

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 20
  • Acute coronary syndrome or stable angina

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary SyndromeAngina, Stable

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Cheol Whan Lee, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 15, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

KR(1)