EUCTR2005-004325-25-DE进行中（未招募）不适用
Comprehensive whole-body 3T MRA of Patients with Low or Moderate Clinical Probability for Pulmonary Embolism using an Intravascular MR Contrast Agent Vasovist®
Administration management, Ludwig-Maximilians-University of Munich0 个研究点目标入组 20 人开始时间: 2006年9月20日最近更新:
适应症
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
- 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
- •Patients with low or moderate clinical probability for pulmonary embolism (Wells score, see appendix 1) and positive or negative CTA for pulmonary embolism.
- •Patients who are willing to undergo MRA with Vasovist® -after getting a detailed information about the treatment by an (co)investigator- and will give their signed informed consent form.
- •The distribution of gender is irrelevant. The patient group reflects the clinic's average.
- •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
- •Less than 18 years of age.
- •Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same days as administration of Vasovist®. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.
- •People with proven central pulmonary embolism (main left or right pulmonary artery)
- •Known underlying pulmonary disease: e.g. lung cancer, chronic obstructive pulmonary disease
- •Having an underlying disease or concomitant medication (or are scheduled for any therapy) which may interfere with efficacy or safety evaluations as planned in this study
- •Having any physical or mental status that interferes with the informed consent procedure incl. self-signed consent.
- •Having a history of alcohol or drug abuse or dependency.
- •Having received any investigational drug within 30 days prior to entering this study or who are planned to receive any other investigational drug during the 24 (+ 4) hours safety follow-up period.
- •Not being able to remain lying down for at least 45 – 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
- •Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
- •Presenting sickle cell disease or other hemolytic anemia.
- •Being clinically unstable
- •Being scheduled for, or likely to require, any surgical intervention within 24 hours before or within the follow-up period.
- •Having any contraindication to MRI examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia).
- •High clinical probability for PE
- •Patient who have received Gadolinum within 24 hours prior to Vasovist® injection.
- •Patients with impaired renal function as indicated by CreatininClearance below 30ml/min (MDRD/Cockroft-Gault) (laboratory diagnostic data required)
- •Patients with impaired liver function (laboratory diagnostic data required)
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