EUCTR2010-021526-36-DE进行中（未招募）1 期
Dynamic and high-resolution MR angiography of the supraaortic vessels at 3 Tesla: Performance of Gadobutrol (Gadovist) in comparison to Gedobenate Dimeglumine (Multihance) and Gadoterate Meglumine (Dotarem) at equimolar dose (0.1 mmol/kg BW) in volunteers and patients with carotid artery stenosis - Gadovist in MR angiography
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •Volunteer part:
- •1.age: at least 18 years
- •2.no history of cardiovascular disease
- •3.willing to undergo all study procedures
- •4.has voluntarily signed and dated the informed consent form
- •Women of childbearing potential:
- •5.a negative pregnancy test (urine test) on the day of contrast agent administration
- •6.use of a highly effective method of birth control during the duration of the study (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner)
- •Patient part:
- •1.age: at least 18 years
- •2.suspicion or proven carotid artery stenosis / stenoses
- •3.willing to undergo all study procedures
- •4.has voluntarily signed and dated the informed consent form
- •Women of childbearing potential:
- •5.a negative pregnancy test (urine test) on the day of contrast agent administration
- •6.use of a highly effective method of birth control during the duration of the study (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Volunteer part:
- •1.if female:, pregnant or nursing
- •2.history of renal disease, subjects in the perioperative liver transplantation period and / or with acute or chronic severe renal impairment
- •3.GFR <60ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 4 weeks before MR contrast agent injection
- •4.contraindications against MR imaging (e.g. subjects with implanted ferromagnetic objects (pacemaker, vascular clip))
- •5.contraindications against any of the three MR contrast agents (e.g. aggravation of anaphylactic-like reactions in patients on beta-blockers, and particularly in the presence of bronchial asthma, low seizure threshold in patients with CNS disorders, patients with uncorrected hypokalemia, severe cardiovascular disease)
- •6.severe claustrophobia
- •7.history of anaphylactoid or anaphylactic reaction to any allergen (e.g. hay fever, urticaria, asthma, history of sensitivity to benzyl alcohol, etc.) including drugs and contrast agents
- •8.having received any investigational drug within 7 days prior to entering this study
- •9.planned to receive any investigational drug during the study period
- •10.close affiliation with the investigational site (e.g., close relative of an investigator)
- •11.participating in another clinical trial
- •12.having been previously enrolled in this clinical trial
- •13.any medical condition that potentially reduces cardiac output
- •Patient part:
- •1.if female:, pregnant or nursing
- •2.history of renal disease, subjects in the perioperative liver transplantation period and / or with acute or chronic severe renal impairment
- •3.GFR <30ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 4 weeks before MR contrast agent injection
- •4.contraindications against MR imaging (e.g. subjects with implanted ferromagnetic objects (pacemaker, vascular clip))
- •5.contraindications against any of the three MR contrast agents (e.g. aggravation of anaphylactic-like reactions in patients on beta-blockers, and particularly in the presence of bronchial asthma, low seizure threshold in patients with CNS disorders, patients with uncorrected hypokalemia, severe cardiovascular disease)
- •6.severe claustrophobia
- •7.history of anaphylactoid or anaphylactic reaction to any allergen (e.g. hay fever, urticaria, asthma, history of sensitivity to benzyl alcohol, etc.) including drugs and contrast agents
- •8.having received any investigational drug within 7 days prior to entering this study
- •9.planned to receive any investigational drug during the study period
- •10.close affiliation with the investigational site (e.g., close relative of an investigator)
- •11.participating in another clinical trial
- •12.having been previously enrolled in this clinical trial
- •13.any medical condition that potentially reduces cardiac output
- •14.prior carotid artery stenting on investigated body side
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