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

June 10, 2013 updated by: Bayer

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

17513

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Many Locations, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who plan to undergo coronary angiography or PCI procedure with ultravist will be enrolled

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Iopromide (Ultravist, BAY86-4877)
Intravenous/intraarterial digital subtraction angiography (DSA); Generally doses of up to 1.5 g iodine per kg body weight are well tolerated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimation of the image quality of Ultravist®
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

September 20, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (ESTIMATE)

September 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15454
  • UV1010CN (OTHER: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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