18F-NaF-PET for Identification of TCFA (NaF-PET)

February 21, 2016 updated by: Bon-Kwon Koo, Seoul National University Hospital

Evaluating the Diagnostic Accuracy of 18F-sodium Fluoride Positron Emission Tomography for Identification of High-risk Vulnerable Coronary Atherosclerotic Plaque in Patients With Coronary Artery Disease

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).

Study Overview

Status

Unknown

Conditions

Detailed Description

It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Until now, evaluation of vulnerable plaque have been mainly performed with invasive imaging modalities such as optical coherence tomography or intravascular ultrasound.

Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies.

In this study, we will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).

Study Type

Observational

Enrollment (Anticipated)

96

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Joo Myung Lee, MD, MPH
        • Sub-Investigator:
          • Paeng Jin Cheol, MD, PhD

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with angina pectoris

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
Time Frame: up to 1 week
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque
Time Frame: up to 1 week
Tissue-to-background ratios were calculated for each participant by dividing the maximal SUV measured in aortic valves by the mean SUV of blood in inferior vena cava
up to 1 week
Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
Time Frame: 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
Time Frame: 1 year
Between High-TBR and Low-TBR Plaque
1 year
Non-fatal target vessel myocardial infarction
Time Frame: 1 year
Between High-TBR and Low-TBR Plaque
1 year
Target vessel revascularization
Time Frame: 1 year
Between High-TBR and Low-TBR Plaque
1 year
Target vessel restenosis
Time Frame: 1 year
Between High-TBR and Low-TBR Plaque
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Bon-Kwon Bon-Kwon, MD, PhD, Seoul National University Hospital
  • Principal Investigator: Paeng Jin Cheol, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 21, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT7895126

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.

Clinical Trials on Acute Coronary Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe