Multicenter Study Into Individualized Scanning for Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of Intravascular Attenuation
研究概览
简要总结
To evaluate intravascular attenuation of the coronary arteries and image quality in an individualized scan and CM injection protocol whereas both scan and injection parameters are tailored to the individual patient in a North American, European and Asian patient population.
To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in an American, European and Chinese patient population.
To evaluate the injection parameters required for an average American, European and Chinese patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
- •Referred for a clinically indicated CCTA scan.
- •Patient aged older than
- •Subject must provide written informed consent prior to any study-related procedures being performed.
- •Subject must be willing to comply with all clinical study procedures.
- •Atypical or typical complaints of angina.
- •No previous cardiovascular history.
- •Possibility of 'flash' mode scan; patient heart rate below 70 beats per minute and regular rhythm.
排除标准
- •The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
- •Contraindications for CT coronary angiography, including:
- •Inability to perform a breath hold for at least the expected scan time
- •Unstable angina
- •Hemodynamic instability
- •Known history of CAD
- •Renal insufficiency (defined as Creatinine <1.5 mg/dL or GFR<30 mL/min)
- •Iodine allergy
- •Insufficient cannula venous access (preferred 18G, minimal 20G cannula)
- •Subject has an acute psychiatric disorder.
- •Subject is unwilling to comply with the requirements of the protocol.
- •Subject has previously entered this study.
结局指标
主要结局
Evaluation of Intravascular Attenuation
时间窗: At time of CCTA scan
To measure the amount of Hounsfield units in different anatomical structures produced by an amount of contrast media. Using Hounsfield units coupled with image quality to determine if a scan of diagnostic value has been attained.
次要结局
未报告次要终点