Treatment Strategy for Critical Lesions of Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major cardiovascular adverse events
研究概览
简要总结
Identifying the critical lesion of coronary artery disease and determining the interventional plan are significant for reducing adverse cardiovascular adverse events. The assessment of critical lesion requires the consideration of plaque morphology, tissue composition, and endometrial stress which leading to rupture. In summary, accurate assessment of critical lesions has high application value. In this study, patients with critical coronary artery disease were divided into two groups: an accurate assessment group and a simple assessment group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis, potential cardiovascular risk, possible "excessive" intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Volunteered to participate in this study and signed an informed consent form;
- •Men or non-pregnant women ≥ 18 and ≤80 years of age;
- •Lesion is located in a coronary artery and stenosis is between 50-75%;
排除标准
- •Severe liver and kidney diseases (GFR<60 ml/min/1.73m2 or CTP≥6 score);
- •Moderate to severe hypertension (after standard antihypertensive therapy, blood pressure higher than 160/100mmHg);
- •Patients with hemodynamic or electrical instability (including shock);
- •Coagulation disorders associated with significant bleeding tendency (eg, hypersensitivity, active bleeding, moderate or severe liver disease, GI bleed within the past 6 months, major surgery within 30 days);
- •Patients with ischemic stroke within one week;
- •Any contraindication against the use of anti-platelet drugs such as aspirin;
- •Platelet count less than 100 x 109/L, haemoglobin (Hb) level less than 100 g/L;
- •Researchers involved in the study and / or immediate family members;
- •Participation in another investigation drug or device study in the past 30 days before enrollment;
- •Involvement in the planning and conduct of the study (applies to staffs at study sites);
- •Suffering from serious arrhythmias include recurrent ventricular tachycardia or ventricular fibrillation;
- •Pregnancy or lactation or females of child-bearing potential with the plan of pregnancy in one year;
结局指标
主要结局
Major cardiovascular adverse events
时间窗: one year after enrollment
Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis
次要结局
- Chest pain(one year after enrollment)
研究者
Genshan Ma
Director of cardiology
Southeast University, China