EUCTR2010-021526-36-DE
Active, not recruiting
Phase 1
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
ConditionsSupraaortic vessel diseasesuspicion or proven carotid artery stenosis / stenosesMedDRA version: 13.1Level: PTClassification code 10007687Term: Carotid artery stenosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Supraaortic vessel disease
- Sponsor
- Klinikum der Universität München
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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