Integrated Coronary Multicenter Imaging Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change of plaque on coronary OCT for during 2 years
研究概览
简要总结
The coronary images of selective angiography and optical coherence tomography with FFR(Fractional Flow Reserve) values of the intermediate lesions (40-70% stenosis) will be prospectively registered.
详细描述
The patients with intermediate lesions after CT angiography and invasive coronary angiography will be screened, and optical coherence tomography, FFR and selective CT angiography will be performed. The coronary images and FFR values will be registered, and the patients will be followed-up up to 2 years to investigate the adverse clinical events.
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 40-70%)
- •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
Change of plaque on coronary OCT for during 2 years
时间窗: at 2-year follow up
Comparison of computational FFR derived from OCT to invasive FFR
时间窗: at 2-year follow up
Change of plaque on coronary CTA for during 2 years
时间窗: at 2-year follow up
Change of FFR value during 2 years
时间窗: at 2-year follow up
次要结局
- Adverse event for 2 years (myocardial infarction, cardiovascular death)(within 2 years after registration)
- Power of plaque characteristics on coronary CTA for predicting adverse events(within 2 years after registration)
- Power of plaque characteristics on OCT for predicting adverse events(within 2 years after registration)