The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Angiocardiography
Intervention: Iopromide (Ultravist, BAY86-4877) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
This study is to collect the information of Ultravist® in the patients indicated for the
coronary angiography or PCI, like rate of ADR in patients, the dose for different
indications, image quality to prove Ultravist the good safety and effectivity
Clinical Details
Official title: This is an International, Prospective, Non-interventional Study, Company Sponsored, Multi-center Study. Patients Undergo Coronary Angiography or PCI Procedure With Ultravist. The Primary Objective is to Evaluate the Safety and Tolerability.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
Secondary outcome: Estimation of the image quality of Ultravist®
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Female and male patients who receive Ultravist® for coronary angiography or PCI can
be included in the study
Exclusion Criteria:
- Patients who are or are suspected in pregnancy or nursery
- Patients with the contraindications for Ultravist
- Patients with the contraindications for cardiac catheterization
Locations and Contacts
Many Locations, China
Additional Information
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Starting date: August 2010
Last updated: June 10, 2013
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