Biological Interconnection of Brain Neurobiological Activity With Atherosclerotic Plaque Vulnerability and the Prognostic Value
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
The effect of brain-heart interaction remains unclear. The study aims to investigate the biological interconnection between brain neural activity and coronary plaque morphological and inflammatory features, as well as their connection with clinical outcomes.
详细描述
Brain neural activity assessed by resting amygdalar activity (AmygA) can predict cardiovascular events. However, its biological interconnection with plaque vulnerability i is not fully understood. Coronary computed tomographic angiography (CCTA) is a non-invasive technique that enables comprehensive assessment of morphological characteristics of coronary atheroma and estimates the level of plaque instability. Recently, perivascular fat attenuation index (FAI) enables assessment of coronary inflammation by analyzing changes of perivascular adipose tissue attenuation in CCTA.
18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including brain neural activity and hematopoiesis.
The present study aims to use ¹⁸F-FDG PET/CT to assess the AmygA, and to investigate its association with CCTA assessed plaque morphological and inflammatory features as well as their ability in predicting future cardiovascular disease events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: greater than 20
- •Patients either absence of prior cancer or remission from cancer for at least 1 year prior to imaging and throughout the follow-up period;
- •Patients absence of acute or chronic inflammatory or autoimmune disease at the time of imaging;
- •Patients with CCTA performed within 90 days of 18F-FDG PET/CT scan as part of routine clinical practice
- •Patients with diameter stenosis >30% by CCTA but without coronary revascularization
排除标准
- •Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
- •Coronary lesion with heavy calcification
- •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 5 year
结局指标
主要结局
Major adverse cardiac events
时间窗: 5 years after index imaging
Death from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina.
Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity)
时间窗: at the index imaging
Amygdalar target-to-background ratio (TBR) = Amygdalar standardized uptake value (SUV) / Temporal lobe SUV Bone marrow TBR = Bone marrow SUV / Jugular vein SUV Correlation between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity) will be assessed
Correlation Between amygdalar activity (neurobiological activity) and high-risk plaque
时间窗: at the index imaging
High-risk plaque features will be assessed by CCTA including positive remodeling (PR, defined as lesion diameter/reference diameter ≥1.1), low attenuation plaque (LAP, defined as a focal central area of plaque with an attenuation density of \<30 Hounsfield Units), spotty calcification (SC, defined as focal calcification within the coronary artery wall \<3mm in maximum diameter), and the "napkin ring" sign (defined as a central area of low attenuation plaque that had a peripheral rim of high attenuation). Correlation Between amygdalar activity and number of high-risk plaque features will be assessed.
Correlation Between amygdalar activity (neurobiological activity) and coronary inflammation
时间窗: at the index imaging
Coronary inflammation will be assessed by FAI. Correlation Between amygdalar activity and FAI will be assessed
次要结局
- Cardiovascular death, or nonfatal myocardial infarction(5 years after index imaging)