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
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
时间窗: up to 1 week
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
次要结局
- Target vessel revascularization(1 year)
- Cardiac death and all-cause mortality(1 year)
- 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)
- Non-fatal target vessel myocardial infarction(1 year)
- Target vessel restenosis(1 year)
研究者
Bon-Kwon Koo
Professor of Internal Medicine and Cardiology Department
Seoul National University Hospital