18F-NaF-PET for Identification of TCFA

Study Overview
=================
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).

Official Title
-----------------
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

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vulnerable plaque in optical coherence tomogrpahy<br>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<br>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 | 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 | 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 | Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque | up to 1 week | 
| Cardiac death and all-cause mortality | Between High-TBR and Low-TBR Plaque | 1 year | 
| Non-fatal target vessel myocardial infarction | Between High-TBR and Low-TBR Plaque | 1 year | 
| Target vessel revascularization | Between High-TBR and Low-TBR Plaque | 1 year | 
| Target vessel restenosis | Between High-TBR and Low-TBR Plaque | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positron emission tomography, Tissue background ratio, Optical coherence tomography, Thin cap fibroous atheroma, Vulnerability, Acute coronary syndrome