Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of major adverse cardiovascular events
研究概览
简要总结
The study is a prospective cohort study conducted in Tianjin Chest Hospital, China. Patients with saphenous vein graft disease after coronary artery bypass graft, and planning for receiving percutaneous coronary intervention after virtual histology intravascular ultrasound will be enrolled between May 2017 and April 2019. These subjects will be followed up at 1, 6 and 12 months post-operation of PCI to assess the short-term and long-term effect.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with SVGD after CABG
- •Planning to receive PCI using drug-eluting stents
- •18 to 80 years old
- •Finishing VH-IVUS examination
- •Willing to participate in the study and sign informed consent
排除标准
- •Patients with liver disfunction and renal failure
- •Aspirin and clopidogrel allergy
- •Acute myocardial infarction after CABG
- •History of stroke in the past 3 months
- •Gastrointestinal bleeding and hemoptysis recently
- •Vasculitis and non-atherosclerotic coronary artery disease
- •Coagulation disorders
- •History of malignancy
- •Women during pregnancy
结局指标
主要结局
Incidence of major adverse cardiovascular events
时间窗: after PCI for saphenous vein graft disease (SVGD) in one year
Cardiac death, myocardial infarction, target lesion revascularization and target vessel revascularization are all major adverse cardiovascular events
次要结局
- Success rate of PCI(24 hours after PCI for the SVGD)
- Thrombolysis In Myocardial Infarction (TIMI) flow in 24 hours after PCI for the SVGD(24 hours after PCI for the SVGD)
- Number of slow reflow, no reflow or distal embolization of the saphenous vein graft after PCI on the basis of Corrected TIMI Frame Count (TFC)(24 hours after PCI for the SVGD)
研究者
Yin Liu
director, Cardiology Department
Tianjin Chest Hospital