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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: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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:

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

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimation of the image quality of Ultravist® [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 17534
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206257

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01206257     History of Changes
Other Study ID Numbers: 15454, UV1010CN
Study First Received: September 20, 2010
Last Updated: December 6, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Bayer:
Survey
Angiography
ADR
Image quality

ClinicalTrials.gov processed this record on May 16, 2013