EUCTR2005-005946-38-DE进行中（未招募）不适用
A DOUBLE-BLIND INTER-INDIVIDUAL COMPARISON OF IOMEPROL 300 AND IOMEPROL 400 IN MULTI-DETECTOR CT ANGIOGRAPHY (MDCTA) OF PERIPHERAL ARTERIES
Bracco ALTANA Pharma GmbH0 个研究点目标入组 64 人开始时间: 2005年12月27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
- 64
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
- •- Indication for Computed Tomographic Angiography (CTA)
- •- Patient is adult (age = 18 years), conscious and co-operative
- •- Written Informed Consent to participate in the study
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Known aortic aneurysm
- •- Major endoprosthesis, which could bias the diagnostic accuracy of MDCTA
- •- Hyperthyroidism (TSH below 0.3 mU/L)
- •- Renal insufficiency (serum creatinine > 1.5 mg/dL)
- •- Hypersensitivity to iodinated contrast media or significant allergic disposition
- •- Insulin-dependent diabetes mellitus, or metformin medication (discontinuation for 48 h enables CT examination of patients with normal renal function)
- •- Known pheochromocytoma or paraproteinaemia
- •- Acute stroke or cerebral oedema
- •- Known Epilepsy; currently active
- •- Planned radioactive iodine therapy
- •- Participation in a clinical trial within the past 30 days
- •- Previous participation in this clinical trial
- •- Alcohol or drug abuse
- •- Patient is female and pregnant or nursing
- •- Patient is female and the possibility of pregnancy cannot be excluded from one of the following points:
- •· surgical sterilization (method has to be recorded on medical history form)
- •· confirmed post-menopausal (with minimum 1-year history without menstruation)
- •· negative pregnancy test (confirmed via ß-HCG measurement)
- •- Patient is institutionalized by law
- •- Circumstances that would significantly decrease the chance of obtaining reliable data or of achieving the study objectives according to the Investigator’s final opinion
- •- Peripheral vein conditions, which would not allow for the required fast administration of contrast agents (18 gauge needle)
研究者
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