Assessment of Subclinical Atherosclerosis Using Dual-source Computed Tomography Coronary Angiography in Chinese Adults With Different Glycaemic Status
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of participants who will develop cardiovascular events during follow-up
研究概览
简要总结
Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different Glycaemic Status
Aims:
To evaluate coronary artery calcification and stenosis in community-dwelling adults with different glycaemic status, using dual-source CT angiography (CTA)
Study Subjects and Methods:
200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then underwent a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis and CTA.
Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery Calcification and Stenosis
Aims and Methods:
To investigate the development of cardiovascular diseases in subjects recruited in part I and re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up
To identify the predictive value of coronary artery calcification and stenosis with future risks of cardiovascular diseases and the possible development of coronary artery disorders among participants with different glycaemic status
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 70 years old
- •Gender: males and females
- •Provide written informed consent
- •Satisfactory compliance
排除标准
- •History of cardiovascular diseases
- •Allergy to iodine
- •Exposure to radiation within last 3 months
- •ALT more than 100IU/L, or serum creatine more than 133μmol/l [1.5mg/dl] or GFR less than 60ml/min
- •Heart rate more than 100 bpm or severe arrhythmia
- •Malignancy, myocardial infection, acute hepatitis or other major diseases
结局指标
主要结局
Number of participants who will develop cardiovascular events during follow-up
时间窗: 3 years
Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. The progression of coronary artery calcium and stenosis is also evaluated at the final visit.
次要结局
未报告次要终点