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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

Page last updated: August 23, 2015

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