EUCTR2010-023001-36-FR进行中（未招募）1 期
Multicenter, open-label study to evaluate the safety and efficacy (byblinded reading) of contrast-enhanced magnetic resonance angiography(MRA) after a single intravenous injection of 0.1 mmol/kg gadobutrol insubjects with known or suspected vascular disease of the supra-aorticvessels - Gadobutrol-enhanced MRA study of the supra-aortic vessels (GEMSAV)
Bayer Health Care AG0 个研究点目标入组 479 人开始时间: 2011年4月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 479
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
- •- Male or female subjects, aged 18 years and older
- •- Any of the following:
- •- Known or suspected supra-aortic arterial disease based on:
- •- Prior stroke
- •- Transient ischemic attack (TIA)
- •- Amaurosis Fugax (transient monocular blindness)
- •- Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
- •- Follow-up for a stent in a supra-aortic vessel
- •- Prior imaging study (Computed Tomographic Angiography [CTA] or ultrasound) showing = 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). [Note:Any CTA must meet the specifications provided in the protocol. If the CTA does not meet the specifications, then the CTA has to be repeated as part of the study or the subject cannot be enrolled.]
- •- Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol
- •- Willingness and ability to follow directions and complete all study procedures specified in the protocol
- •- Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug
- •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
- •- Pregnant or nursing (including pumping for storage and feeding)
- •- Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
- •- Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol
- •- Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
- •- Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])
- •- History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
- •- Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)
- •- Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)
- •- Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
- •- Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
- •- Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery)
- •- Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:
- •- Any procedure that may alter the MRA or CTA interpretation, or
- •- Any interventional or surgical procedure involving the supra-aortic vessels
研究者
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