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OpenTrials
Completed

NCT Number: NCT01206257

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

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

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Key information

Conditions

Angiocardiography

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iopromide (Ultravist, BAY86-4877)

Drug

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

Primary outcomes

  1. Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.

    Time frame: 12 months

Secondary outcomes

  1. Estimation of the image quality of Ultravist®

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Acronym: TRUST

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 21, 2010
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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