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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: September 20, 2010
Last updated: June 10, 2013
Last verified: June 2013
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

Condition Intervention
Angiocardiography Drug: Iopromide (Ultravist, BAY86-4877)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Estimation of the image quality of Ultravist® [ Time Frame: 12 months ]

Enrollment: 17513
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who plan to undergo coronary angiography or PCI procedure with ultravist will be enrolled

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01206257

Many Locations, China
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare AG Identifier: NCT01206257     History of Changes
Other Study ID Numbers: 15454
UV1010CN ( Other Identifier: company internal )
Study First Received: September 20, 2010
Last Updated: June 10, 2013

Keywords provided by Bayer:
Image quality processed this record on September 21, 2017