The Ontario Multidetector Computed Tomography (MDCT) Coronary Angiography Study (OMCAS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 8
- 主要终点
- Sensitivity and specificity of MDCTCA as compared to CICA
研究概览
简要总结
Multidetector Computed Tomographic Coronary Angiography (MDCTCA) has been recently demonstrated to be accurate and may be used as a potential alternative to conventional invasive coronary angiography, which requires cardiac catheterization, for the diagnosis of coronary artery disease. The purpose of this study is to see if MDCTCA can identify significant coronary artery disease as good as or better than conventional coronary angiography (CICA). The study is designed to enroll 900 subjects and is being conducted in 6 hospitals in Ontario. Subjects scheduled for conventional cardiac catheterization and coronary angiography will receive an additional test using MDCTCA. The information gathered during the MDCTCA will be compared to the results of the scheduled conventional invasive coronary angiogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Valvular heart disease (mitral stenosis, mitral regurgitation, aortic stenosis or aortic insufficiency) or
- •Congenital heart disease (i.e. VSD, ASD, PDA) or
- •Cardiomyopathy OR
- •Intermediate probability of coronary artery disease (probability of 10-90%) after clinical evaluation and traditional non-invasive testing
排除标准
- •Age < 18 years
- •Lack of consent
- •Renal Insufficiency (GFR < 60 mL/min)
- •Allergy to contrast agent
- •Refractory angina requiring urgent/emergent coronary angiography (as per treating physician)
- •Pregnancy or breast feeding
- •Uncontrolled heart rate
- •Previous CABG or PCI/Stent
- •Chronic atrial fibrillation
- •History of acute myocardial infarction, as defined by a creatine kinase (CK) level greater than 2 times normal with a troponin level above
- •Unable to perform 20 second breath-hold
结局指标
主要结局
Sensitivity and specificity of MDCTCA as compared to CICA
时间窗: After both MDCTCA and CICA are completed
次要结局
- Descriptive statistics (rates and proportions) will be calculated for the number of "avoidable" diagnostic cardiac catheterizations.(After both MDCTCA and CICA are completed)
- The accuracy of MDCTCA to CICA will be compared in categorizing patients inot single, double, triple vessel, left main disease or no coronary stenosis.(After both MDCTCA and CICA are completed)
- The accuracy of MDCTCA to eliminate correctly the need for CICA will be calculated.(After both MDCTCA and CICA are completed)