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18F-NaF-PET for Identification of TCFA

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02388412
Acronym
NaF-PET
Enrollment
96
Registered
2015-03-17
Start date
2015-03-31
Completion date
2018-03-31
Last updated
2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Positron emission tomography, Tissue background ratio, Optical coherence tomography, Thin cap fibroous atheroma, Vulnerability, Acute coronary syndrome

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).

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).

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaqueup to 1 weekDifference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque

Secondary

MeasureTime frameDescription
Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaqueup to 1 weekNumber of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
Cardiac death and all-cause mortality1 yearBetween High-TBR and Low-TBR Plaque
Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaqueup to 1 weekTissue-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
Non-fatal target vessel myocardial infarction1 yearBetween High-TBR and Low-TBR Plaque
Target vessel revascularization1 yearBetween High-TBR and Low-TBR Plaque
Target vessel restenosis1 yearBetween High-TBR and Low-TBR Plaque

Countries

South Korea

Contacts

Primary ContactBon-Kwon Koo, MD, PhD
bkkoo@snu.ac.kr82-2-2072-2062
Backup ContactJoo Myung Lee, MD, MPH
drone80@hanmail.net82-2-2072-2062

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026