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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01206257
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : June 11, 2013
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment
Angiocardiography Drug: Iopromide (Ultravist, BAY86-4877)

Study Type : Observational
Actual Enrollment : 17513 participants
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.
Study Start Date : August 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Iopromide
U.S. FDA Resources

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.



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

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


Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206257


Locations
China
Many Locations, China
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01206257     History of Changes
Other Study ID Numbers: 15454
UV1010CN ( Other Identifier: company internal )
First Posted: September 21, 2010    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Keywords provided by Bayer:
Survey
Angiography
ADR
Image quality