Comparison of two Gadolinium containing MR contrast media in patients with symptoms of cerebrovascular disease

• Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]; Patients with high grade carotid artery stenosis or acute cerebral ischemia

• Registration Number: EUCTR2012-001582-33-DE
• Lead Sponsor: niversity Hospital Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-03
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. adult patients, age 18-85 years
2. with clinically suspected or definite ischemic stroke or an intracranial stenosis (> 50% degree) or extracranial stenosis of the internal carotid artery (> 70%)
3. clinically indicated initial and follow-up MR examinations of the brain with contrast injection
4. willing to undergo and comply with all study procedures
5. written informed consent
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 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. who are in pregnancy or nursery. In women with child bearing potential a pregnancy test must be performed directly before each MR examination in order to safely exclude pregnancy. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.
2. with impaired renal function of CKD stadium 3 and higher (i.e. creatinine clearance < 60 ml/min/1.73m² (Cockroft-Gault formula) or patients on hemodialysis. In patients with known renal impairment, clearance will be calculated based on serum creatinine level using the Cockroft-Gault formula. Calculation of the clearance must be done before begin of study. Serum creatinine value must not be older than one week (7 days) before study related contrast injection.
3. with renal or liver transplant, including patients with scheduled liver transplant 4. with known allergy or any contraindication to Gadobutrol or Gadoterate.
5. presenting with a history of anaphylactoid or anaphylactic reaction to any drug or contrast agent.
6. with high grade cardiac arrhythmia
7. not being able to remain lying down for at least 30-45 min (e.g., patients with unstable angina, dyspnoea at rest, severe pain at rest, severe back pain)
8. having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
9. with a contraindication for MRI (pacemaker, magnetic clips, severe claustrophobia etc.)
10. being clinically unstable or requiring emergency treatment
11. with close affiliation with the investigational site; e.g. a close relative of the investigator
12. who have received any investigational drug within 7 days prior to entering this study
13. who have received any contrast agent within 24 hours prior to entering this study
14. who have previously entered this study
15. participating in another clinical trial
16. having an underlying disease or concomitant medication which may interfere with efficacy evaluation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified