EUCTR2007-003197-26-IT进行中（未招募）不适用
Studio randomizzato di fase IV, doppio cieco, multicentrico, per il confronto di Iomeron 400 con Visipaque 320 nell'angiografia coronarica con Tomografia Computerizzata a doppio tubo (DS-CTA) - Coronary Dual Source CTA
BRACCO IMAGING0 个研究点目标入组 96 人开始时间: 2008年1月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Can provide written informed consent and are willing to comply with protocol requirements; Is at least 18 years of age; Weighs less than 150 kg; Is scheduled for Computed Tomography due to suspicion of CAD.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Has a history of hypersensitivity to iodinated contrast agents; Has known or suspected hyperthyroidism or pheochromocytoma; Has renal impairment (eGFR <60 mL/min/1.73 m2 [using the abbreviated MDRD formula] or SCr >1.5 mg/dL); Has atrial fibrillation or any other cardiac rhythm that precludes reliable ECG triggering; Has severe congestive heart failure, New York Heart Classification (NYHA) Class IV; Is a pregnant or lactating female. Was previously entered into this study; Has received an investigational compound within 30 days before the admission into the study; Has received an iodinated contrast agent within 7 days prior to administration of Investigational Product (IP) or is scheduled to receive within 2 hours after IP administration (for the definition of IP, see section 6) other than for a related coronary angiography procedure; Is institutionalized by law; Is determined by the Investigator to be clinically unsuitable for the study; Has peripheral vein conditions that would not allow for the required fast administration of contrast agents (18 gauge needle); Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
研究者
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