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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01206257
Acronym
TRUST
Enrollment
17513
Registered
2010-09-21
Start date
2010-08-31
Completion date
2011-09-30
Last updated
2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiocardiography

Keywords

Survey, Angiography, ADR, Image quality

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

Interventions

Intravenous/intraarterial digital subtraction angiography (DSA); Generally doses of up to 1.5 g iodine per kg body weight are well tolerated.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.12 months

Secondary

MeasureTime frame
Estimation of the image quality of Ultravist®12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026