GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

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

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Key information

Conditions

Magnetic Resonance Imaging Magnetic Resonance Angiography

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Bosnia and Herzegovina

About this study

Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).

Exclusion criteria

There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.

Treatment and study plan

Gadobutrol (Gadovist, BAY86-4875)

Drug

Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.

Primary outcomes

Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups

Time frame: 1 day

Secondary outcomes

Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered.

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: GARDIAN

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Mar 29, 2010
Registry last updated: Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed