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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206257
First Posted: September 21, 2010
Last Update Posted: June 11, 2013
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.
Information provided by:
Bayer
September 20, 2010
September 21, 2010
June 11, 2013
August 2010
September 2011   (Final data collection date for primary outcome measure)
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization. [ Time Frame: 12 months ]
To evaluate the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization. [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01206257 on ClinicalTrials.gov Archive Site
Estimation of the image quality of Ultravist® [ Time Frame: 12 months ]
To estimate the image quality of Ultravist® [ Time Frame: 12 months ]
Not Provided
Not Provided
 
The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)
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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients who plan to undergo coronary angiography or PCI procedure with ultravist will be enrolled
Angiocardiography
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.
Group 1
Intervention: Drug: Iopromide (Ultravist, BAY86-4877)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17513
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01206257
15454
UV1010CN ( Other Identifier: company internal )
No
Not Provided
Not Provided
Medical Director, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2013