check_circleStudy Completed

Angiocardiography

Bayer Identifier:

15454

ClinicalTrials.gov Identifier:

NCT01206257

EudraCT Number:

Not Available

EU CT Number:

Not Available
The safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)

Trial 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

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study

  • - Patients who are or are suspected in pregnancy or nursery
    - Patients with the contraindications for Ultravist
    - Patients with the contraindications for cardiac catheterization

Trial summary

Enrollment Goal
17513
Trial Dates
August 2010 - September 2011
Phase
N/A
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, China

Primary Outcome

  • Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    Yes

Secondary Outcome

  • Estimation of the image quality of Ultravist®
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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