Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study").
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Detection of > 50% coronary stenosis
研究概览
简要总结
Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with idiopathic cardiomyopathy in sinus rhythm, compared to conventional coronary angiography.
详细描述
The principal aim of this study is to assess the diagnostic accuracy (sensitivity, specificity, predictive values) of multislice spiral computed tomography (MSCT) coronary angiography among patients having idiopathic hypokinetic dilated cardiomyopathy in sinus rhythm, compared to conventional coronary angiography. The secondary aims are to assess the performance of MSCT in coronary sinus anatomy assessment, and in quantitative measurement of left ventricular anatomical criteria (telediastolic diameter, septal and posterior wall thickness, and ejection fraction) compared to echocardiography. Lastly, renal tolerance of MSCT will be studied. This prospective monocentric study will include 120 patients scheduled to undergo coronary angiography for etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease) in sinus rhythm. MSCT will be performed within 3 months after conventional coronary angiography, with blinded analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •patients scheduled to undergo coronary angiography,
- •etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease),
- •in sinus rhythm,
- •informed written consent.
排除标准
- •allergy to iodine,
- •history of coronary artery bypass graft,
- •history of percutaneous coronary angioplasty,
- •history of myocardial infarction,
- •known coronary artery disease,
- •Q waves on the ECG,
- •unstable haemodynamic status,
- •urgent revascularisation or urgent valvular surgery,
- •heart rate > 80 bpm (before MSCT),
- •pregnancy,
- •enrollment in another study.
- •severe renal or respiratory insufficiency.
结局指标
主要结局
Detection of > 50% coronary stenosis
时间窗: During assessment
Sensibility, specificity, positive and negative predictive values of MSCT
时间窗: During assessment
次要结局
- Detection of patients with one or more coronary stenosis(During assessment)
- Detection of patients with 3-vessel disease(During assessment)
- Left ventricle telediastolic diameter(During assessment)
- Septal telediastolic thickness(During assessment)
- Posterior wall telediastolic thickness(During assessment)
- Detection of coronary sinus branches(During assessment)
- Measurement of coronary sinus branches diameter(During assessment)
- Assessment of renal function 7 days after MSCT(During assessment)