Magnetic Resonance Imaging, Magnetic Resonance Angiography
Conditions
Brief summary
Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients
Detailed description
Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
Interventions
Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).
Exclusion criteria
* There are no other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered. | 1 day |
Countries
Bosnia and Herzegovina, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Kazakhstan, Kyrgyzstan, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Vietnam
Outcome results
None listed