NCT02388412

Brief Summary

Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies. In this study, the investigators will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

March 4, 2015

Last Update Submit

February 21, 2016

Conditions

Acute Coronary Syndrome

Keywords

Positron emission tomographyTissue background ratioOptical coherence tomographyThin cap fibroous atheromaVulnerabilityAcute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque

    Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque

    up to 1 week

Secondary Outcomes (6)

  • Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque

    up to 1 week

  • Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque

    up to 1 week

  • Cardiac death and all-cause mortality

    1 year

  • Non-fatal target vessel myocardial infarction

    1 year

  • Target vessel revascularization

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Vulnerable plaque in optical coherence tomogrpahy

OCT-derived vulnerable plaque is defined as composite of thin-cap fibrous atheroma (cap thickness in optical coherence tomography \< 60um), prominent macrophage, or prominent microvessels.

Non-vulnerable plaque in Optical coherence tomogrpahy

OCT-derived vulnerable plaque is defined as composite of thin-cap fibrous atheroma (cap thickness in optical coherence tomography \< 60um), prominent macrophage, or prominent microvessels. OCT-derived non-vulnerable plaque is defined as a plaque without any of the findings

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with angina pectoris

You may qualify if:

  • \. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
  • \. Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by coronary CT angiography.
  • \. Patients who are anticipated coronary artery disease.(Probability \> 90 %)
  • \. Acute coronary syndrome.

You may not qualify if:

  • \. Stenosis at distal coronary or small vessel.
  • \. Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
  • \. Inadequate quality of 18F-NaF PET-CT
  • \. Inadequate quality of Optical Coherence Tomography (OCT), IVUS, Coronary CT angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Lee JM, Bang JI, Koo BK, Hwang D, Park J, Zhang J, Yaliang T, Suh M, Paeng JC, Shiono Y, Kubo T, Akasaka T. Clinical Relevance of 18F-Sodium Fluoride Positron-Emission Tomography in Noninvasive Identification of High-Risk Plaque in Patients With Coronary Artery Disease. Circ Cardiovasc Imaging. 2017 Nov;10(11):e006704. doi: 10.1161/CIRCIMAGING.117.006704.

    PMID: 29133478DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Bon-Kwon Bon-Kwon, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

  • Paeng Jin Cheol, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bon-Kwon Koo, MD, PhD

CONTACT

82-2-2072-2062bkkoo@snu.ac.kr

Joo Myung Lee, MD, MPH

CONTACT

82-2-2072-2062drone80@hanmail.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine and Cardiology Department

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

KR(1)