18F-NaF-PET for Identification of TCFA

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT02388412
• Lead Sponsor: Seoul National University Hospital

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).

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-17
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-21
• Last Update Posted: 2016-02-23
• Primary Completion: 2017-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque	up to 1 week	Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque

Secondary Outcome Measures

Name	Time	Method
Target vessel revascularization	1 year	Between High-TBR and Low-TBR Plaque
Cardiac death and all-cause mortality	1 year	Between High-TBR and Low-TBR Plaque
Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque	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
Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque	up to 1 week	Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
Non-fatal target vessel myocardial infarction	1 year	Between High-TBR and Low-TBR Plaque
Target vessel restenosis	1 year	Between High-TBR and Low-TBR Plaque

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of