Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors: "CORE-64" Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 405
- 主要终点
- Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.
研究概览
简要总结
To compare the diagnostic ability of 64-detector MDCT coronary angiography with conventional invasive coronary angiography in patients with suspected coronary artery disease.
详细描述
The "Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors" or "CorE-64" study was designed to evaluate the diagnostic accuracy of multislice spiral CT angiography using 64 detector rows for identifying coronary artery stenosis in patients with suspected or known coronary artery disease. The study was designed as a prospective, multi-center, international, blinded study examining the diagnostic accuracy of 64-slice CT in comparison with CCA. The primary hypothesis of the study is that 64-slice CT coronary angiography will be able to detect significant coronary artery disease in a patient with acceptable diagnostic accuracy as compared to CCA. Significant CAD is defined as ≥ 50% stenosis as determined by quantitative analysis of CCA (QCA). The diagnostic parameters is per-patient sensitivity and specificity compared with CCA, with both point estimates and continuous measurements of diagnostic accuracy. Eligible patients will first undergo MDCT (calcium scanning and MDCTA)prior to clinically indicated conventional coronary angiography. Patients with CAC 600 or less will be included in the primary analysis. Patients will be followed for clinical events including revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, age 40 years or greater.
- •Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
- •Suspected coronary artery disease (i.e. symptoms, signs) with a clinical indication for coronary angiography; and planned coronary angiography within the next 30 days.
- •Able to understand and willing to sign informed consent.
排除标准
- •Known allergy to iodinated contrast media
- •History of contrast-induced nephropathy
- •History of multiple myeloma or previous organ transplantation
- •Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula
- •Atrial fibrillation or uncontrolled tachyarrhythmia, or heart block
- •Evidence of severe symptomatic heart failure; moderate or severe aortic stenosis
- •Previous coronary artery bypass or other cardiac surgery
- •Coronary artery intervention within the last 6 months
- •Intolerance or contraindication to beta-blockers
- •Body Mass Index > 40.
结局指标
主要结局
Diagnostic Accuracy to detect significant coronary artery disease in an individual patient.
时间窗: 30 Days
次要结局
- Diagnostic Accuracy to detect significant coronary artery disease in an individual vessel.(30 Days)