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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01206257
First received: September 20, 2010
Last updated: June 10, 2013
Last verified: June 2013

September 20, 2010
June 10, 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 ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01206257 on ClinicalTrials.gov Archive Site
Estimation of the image quality of Ultravist® [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To estimate the image quality of Ultravist® [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01206257
15454, UV1010CN
No
Medical Director, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP