Biological Interconnection Between Stress-associated Neurobiological Activity and Atherosclerotic Plaque Instability: A Prospective Cohort Study With OCT-FLIM Dual-modal Intravascular Imaging and Serial 18F-FDG-PET/CT Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Baseline amygdalar activity (Stress-associated neurobiological activity)
研究概览
简要总结
Emotional stress is associated with future cardiovascular events. However, the biological interconnection between brain emotional neural activity and acute plaque instability is not fully understood. Optical coherence tomography-Fluorescence Lifetime (OCT-FLIM) dual modal intravascular imaging is a novel technique that enables comprehensive assessment of structural and biochemical characteristics of coronary atheroma and estimates the level of plaque instability. 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including emotional stress, arterial inflammation, and hematopoiesis. The present study aims to prospectively investigate mechanistic linkage between coronary plaque instability, stress-associated neurobiological activity, and macrophage hematopoiesis using OCT-FLIM and 18F-FDG PET/CT imaging assessment.
详细描述
Thirty two patients with multivessel coronary artery disease (including both stable angina and acute coronary syndrome), who have at least one severe obstructive lesion (>70% diameter stenosis) that is considered suitable for percutaneous coronary intervention (PCI), will be included in the study.
Structural/biochemical characteristics of coronary culprit plaque (with or without mild to moderate stenotic non-culprit plaque) will be assessed comprehensively using OCT-FLIM dual modal intravascular imaging.
After coronary revascularization with PCI, subjects will undergo serial 18F-FDG-PET/CT molecular imaging at baseline admission and 6-month follow-up to measure PET signal activities at target tissues including amygdala, carotid artery, aorta, bone marrow, and spleen.
Correlation between OCT-FLIM parameters and baseline PET signals will be assessed to provide insight into the mechanistic linkage between multi-system metabolic activities and coronary plaque instability. Serial PET/CT imaging after 6 month will enable estimation of natural course of multi-system PET signal activities according to different levels of coronary plaque instability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: greater than 20, less than 75
- •Patients with severe coronary atherosclerosis (diameter stenosis >70%) requiring coronary revascularization
- •Reference vessel diameter: between 2.5 and 4.0 mm
- •Obtained informed consent from voluntary participants before study enrollment
排除标准
- •Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
- •Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm
- •Coronary lesion with heavy calcification
- •Hemodynamic instability during coronary intervention
- •Contraindication to antithrombotic therapy
- •Chronic renal insufficiency (Serum creatinine >2.0mg/dL)
- •Severe liver dysfunction (aspartate transaminase or alanine transferase > 5 times of upper normal limit)
- •Pregnancy or potential pregnancy
- •Life expectancy less than 1 year
- •Patient refused to sign the informed consent at enrollment
结局指标
主要结局
Baseline amygdalar activity (Stress-associated neurobiological activity)
时间窗: Baseline (within index admission)
Amygdalar target-to-background ratio (TBR) = Amygdalar standardized uptake value (SUV) / Temporal lobe SUV
次要结局
- Baseline carotid inflammation (arterial atherosclerotic inflammation)(Baseline (within index admission))
- Baseline aortic inflammation (arterial atherosclerotic inflammation)(Baseline (within index admission))
- Coronary plaque composition estimated by OCT-FLIM(Baseline (day 1))
- Baseline bone marrow hematopoiesis (hematopoietic activity)(Baseline (within index admission))
- Baseline splenic hematopoiesis (hematopoietic activity)(Baseline (within index admission))
研究者
Jin Won Kim
Principal Investigator
Korea University Guro Hospital