NCT04153903Enrolling By Invitation不适用
Integrated Coronary Multicenter Imaging Registry - Extended
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparison of computed FFR derived by coronary images and real FFR values
研究概览
简要总结
The coronary images of invasive angiography and optical coherence tomography (or Coronary CT angiography) with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis) will be prospectively registered.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent coronary CT angiography because of chest pain
- •Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 50-70%)
- •Age: 20-80 yrs
- •Patients who consent and fully understand the protocol
- •Patients who consent the clinical follow-up
- •Patients who can be followed-up
排除标准
- •Patients who had contrast allergy
- •Patients who had unstable blood pressure needing the vasopressors
- •Patients who had severe left ventricular function (left ventricular ejection fraction<30%)
- •Chronic kidney disease who had Cr level of greater than 2.0 mg/dl
- •Patients whose expected survival is less than 12 months
- •Patients who had a severe valvular disease
结局指标
主要结局
Comparison of computed FFR derived by coronary images and real FFR values
时间窗: at registration
FFR values computed by OCT/CT/invasive coronary angiography will be compared by real invasive FFR values
次要结局
- Adverse event (Death, acute myocardial infarction)(2 years after registration)
研究者
研究点 (1)
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