Phase 3, Open-label, Multicenter Studies to Determine Efficacy and Safety of VISIPAQUETM (Iodixanol) Injection for Use in Intravenous Contrast-Enhanced CT Angiography of Coronary Arteries
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 89
- 主要终点
- To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction
研究概览
简要总结
CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body.
VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥18 years old.
- •Subject must have been referred for an elective coronary angiography for one of several specified conditions.
排除标准
- •The subject has impaired renal function with a serum creatinine level ≥1.7 mg/dL (150 µmol/L). If the institution's practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dL (150 µmol/L), the investigator should follow the practising guideline(s) of their institution.
- •Subject has a known allergy to iodinated contrast agent
- •Subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac CT images.
- •The subject's resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated.
- •Use of nitroglycerin is contraindicated.
- •Subject has had a prior CABG procedure.
- •Subject has a metal cardiac stent in place or artificial heart valve(s).
- •Subject has had a prior pacemaker or internal defibrillator lead implantation. Subject must agree to discontinue metformin day of and for 48 hours after the CTA procedure.
研究组 & 干预措施
Visipaque Injection
All participants will receive intravenous (IV) administration of 80 mL Visipaque (iodixanol) 320 mg-I/mL at a rate of 4-5 mL per second via power injector followed by a saline injection of 40-50 mL 0.9% sodium chloride solution at a rate of 4-5 mL per second.
干预措施: iodixanol (Drug)
结局指标
主要结局
To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction
时间窗: 48 hours
次要结局
未报告次要终点