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Clinical Trials/NCT01206257
NCT01206257
Completed
Not Applicable

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.

Bayer0 sites17,513 target enrollmentAugust 2010
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ConditionsAngiocardiography
InterventionsIopromide (Ultravist, BAY86-4877)
DrugsIopromide (Ultravist, BAY86-4877)

Overview

Phase
Not Applicable
Intervention
Iopromide (Ultravist, BAY86-4877)
Conditions
Angiocardiography
Sponsor
Bayer
Enrollment
17513
Primary Endpoint
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
September 2011
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayer

Eligibility 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

Arms & Interventions

Group 1

Intervention: Iopromide (Ultravist, BAY86-4877)

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Secondary Outcomes

  • Estimation of the image quality of Ultravist®(12 months)

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