Comparison of Image Content Assessment Between Dural-axis Rotational and Standard Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Diagnosis of Coronary Heart Disease
研究概览
简要总结
The investigators hypothesized that dual-axis rotational coronary angiography was non-inferior to standard coronary angiography with respect to diagnosis of coronary artery disease.
详细描述
The prior studies have demonstrated that dual-axis rotational coronary angiography (DARCA) is associated with lower contrast usage and radiation exposure compared with standard coronary angiography (SA). Single-axis rotational coronary angiography (RA) has been proved by previous studies without any reduction in diagnostic accuracy compared to SA. However, the rotational protocol is obvious different between DARCA and single-axis RA. A recent study has assessed the diagnostic accuracy of DARCA, but this study was not designed for image content analysis and the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The diagnostic accuracy of DARCA aroused our attention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years old, <80 years old
- •a clinical indication for diagnostic coronary angiography to evaluate possible coronary artery disease
排除标准
- •Pregnancy
- •Known allergy to iodinated contrast
- •Patients who had received iodinated contrast material within the last week or were unable to give consent
- •Renal insufficiency (>1.5mg/dL)
- •Acute myocardial infarction within one week
- •Cardiogenic shock
- •heart function worse than New York Heart Association functional class III
- •Left main coronary artery disease
- •Prior coronary artery bypass graft treatment
- •Prior percutaneous coronary intervention treatment
结局指标
主要结局
Diagnosis of Coronary Heart Disease
时间窗: After coronary angiography, an expected average of 1 month
The number of patients diagnosed as coronary heart disease by either angiographic modality by two blinded independent reviewers are recorded. The single criterion for diagnosis of coronary heart disease is the presence of coronary artery stenoses greater than or equal to 50%.
次要结局
- Coronary Lesion Assessment(After coronary angiography, an expected average of 1 month)
- Diagnostic Screening Adequacy(After coronary angiography, an expected average of 1 month)
- Quantitative Coronary Angiography(After coronary angiography, an expected average of 1 month)