EUCTR2006-000929-59-DE进行中（未招募）不适用
INTRAINDIVIDUAL CROSS-OVER STUDY TO COMPARE MULTIHANCE® AND MAGNEVIST® AT A DOSE OF 0.1 MMOL/KGBW IN CERVICO-CEREBRAL MR ANGIOGRAPHY AND CEREBRAL MR PERFUSION IMAGING AT 3 TESLA IN PATIENTS WITH CAROTID ARTERY STENOSIS
Bracco ALTANA Pharma GmbH0 个研究点开始时间: 2006年11月22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
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
- •1. Patient suffers from a stenosis of the internal carotid artery (ICA), is scheduled for MRA, for MR perfusion examination and for an elective stent treatment;
- •2. Patient is adult (age, > or =18 years), conscious and co-operative;
- •3. Patient provides 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient has a body weight > or = 100 kg;
- •2. Patients with a severe heart failure (NYHA class IV);
- •3. Patients with renal insufficiency (creatinine clearance < or = 60 ml/min);
- •4. Patients with known, hemodynamic stenosis (>60 %) of the contralateral carotid artery;
- •5. Intra-vascular MR contrast agent procedure within 36 hours preceding each study MR examination;
- •6. Patient with a history of hypersensitivity to any metals or to chelates of Gadolinium;
- •7. Significant allergic disposition;
- •8. Patient with pacemakers, ferro-magnetic material such as surgical clips or any other conditions that would preclude proximity to a strong magnetic field;
- •9. Patient is suffering from severe claustrophobia;
- •10. Patient with any medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives, i.e.:
- •- drug dependence,
- •- psychiatric disorder, dementia, or other reasons for expected poor compliance with investigator’s instructions,
- •- medical conditions, associated illness, or extenuating circumstances that make it highly unlikely that the patient can complete the study;
- •11. Patient is female and pregnant or nursing;
- •12. 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);
- •13. Patient is currently participating or has previously participated in a study (in which an investigational drug was dispensed) within 30 days prior to admission to this study;
- •14. Patient has previously entered this study;
- •15. Patient without legal capacity (i.e. prisoners).
研究者
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