Randomized Study on the Safety and Efficacy of Dual-axis Rotational Versus Standard Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 576
- 试验地点
- 1
- 主要终点
- Clinical safety of the patient during coronary angiography(CA)
研究概览
简要总结
The purpose of this study is to assess the clinical safety and efficacy of dual-axis rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by directly comparing it to standard coronary angiography (SA).
详细描述
Dual-axis rotational coronary angiography (DARCA) was developed as an innovative adaptation of rotational angiography (RA), but it requires a longer coronary injection compared to standard coronary angiography (SA). The risk of complications from the contrast agent (such as discomfort, warmth, pain, hypotension and bradycardia) is increased with the use of DARCA. It remains to be evaluated whether this approach is also suitable for coronary angiography, especially using in the patients with complex coronary lesions. Previous studies revealed promising results, but the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The purpose of this study is to evaluate the feasibility, safety, clinical tolerance, and hemodynamic effect of DARCA in comparison to the well-established SA.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •A clinical indication for diagnostic coronary angiography to evaluate possible CAD
排除标准
- •Pregnancy
- •Known allergy to iodinated contrast
- •Renal insufficiency (>1.5mg/dL)
- •Cardiogenic shock
- •Acute myocardial infarction within one week
- •Prior coronary artery bypass graft treatment
- •Prior percutaneous coronary intervention treatment
结局指标
主要结局
Clinical safety of the patient during coronary angiography(CA)
时间窗: At time of CA
The patients were closely observed and questioned regarding discomfort and adverse events during or immediately after CA. The sensation of warmth or pain, including chest pain, is considered as discomfort. Adverse events include arrhythmias, hemodynamic compromise, chest pain described as angina-like pain and any untoward event which jeopardises the patient's life or prolongs the planned hospital stay. If patients experienced bradycardia, only bradycardia with a decrease in heart rate of 20% from the baseline was counted. Hemodynamic compromise was defined as a decrease in systolic blood pressure by \> 20 mmHg to \< 90 mmHg.
次要结局
- Patient safety determined by contrast and radiation dose(At time of CA)
- Clinical utility of dual-axis rotational coronary angiography(DARCA)(At time of CA)