Diagnostic Performances of the Computed Tomographic Coronary Angiography and IntraVascular UltraSound to Evaluate Ischemia Causing Coronary Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess precise anatomical information. Optimal functional criteria and their accuracy of IVUS and CCTA by fraction flow reserve (FFR) have not been compared yet.
详细描述
Correlation between CCTA, IVUS and FFR will be evaluated. The presence of myocardial ischemia will be assessed by fractional flow reserve (FFR).
Diagnostic performance (sensitivity, specificity, positive predictive/negative predictive values and diagnostic accuracy) of each modality will be assessed and compared.
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 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients presenting chest pain suspected stable angina or unstable angina
- •patients permit informed consents
- •patients performed all the procedures including CCTA, IVUS and FFR and present coronary artery stenosis
排除标准
- •acute myocardial infarction
- •ejection fraction less than 40%
- •infarct related artery
- •chronic renal insufficiency
- •left main stenosis, in-stent restenosis and grafted vessels
- •allergy in contrast agent and adenosine
- •unable to get a informed consents
结局指标
主要结局
Diagnostic accuracy
时间窗: 1 day
Evaluate and compare the diagnostic accuracy of the CCTA, IVUS and angiographic parameters for the prediction of myocardial ischemia (FFR\<0.8) 1. CCTA: % area stenosis 2. IVUS: minimum lumen area 3. Angiography: % diameter stenosis Diagnostic accuracy of each parameter: (true positive+true negative)/total cases
次要结局
未报告次要终点
研究者
Bon-Kwon Koo
Associate professor
Seoul National University Hospital