The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)

Completed

• Conditions: Angiocardiography
• Interventions: Drug: Iopromide (Ultravist, BAY86-4877)

• Registration Number: NCT01206257
• Lead Sponsor: Bayer

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17513

Inclusion Criteria

• Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Iopromide (Ultravist, BAY86-4877)	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.	12 months

Secondary Outcome Measures

Name	Time	Method
Estimation of the image quality of Ultravist®	12 months