check_circleStudy Completed

Contrast enhanced X-ray based examination

A study, called UV Population, to learn more about the safety of the study drug Ultravist, which is given to get clearer X-ray pictures, in people of different sexes, races, and from different countries/regions

Trial purpose

This is an observational study in which patient data from the past of people who received Ultravist prior to an X-ray based scan are studied.
In observational studies, only observations are made without specified advice or interventions.
X-ray based imaging like computed tomography or angiography is used to make pictures of the structures inside the body. These pictures are needed in various medical situations. In some X-ray tests, the patient is given a compound called “contrast agent” that is injected into the vein. It helps to create clearer pictures as it makes internal body structures easier to see. With such contrast-enhanced imaging techniques, doctors can better see certain problems.
Ultravist is an iodine-based contrast agent. It is also called iopromide, and it is available for doctors to give patients before they have X-ray based scans.
Clinical studies on the overall safety of Ultravist have shown that hypersensitivity reactions (HSRs) may rarely occur. HSRs are undesirable reactions of the body’s defense system (immune system) to the study drug. However, more information on HSRs is needed.
The main aim of this study is to find out whether certain groups of people are more likely to have HSRs after Ultravist injection than others (e.g., depending on gender, race, or country/region).
To do this, researchers will collect data from people with HSRs (all ages) after contrast-enhanced X-ray scans with Ultravist. These data come from four observational studies that have already been completed. Participants who had HSRs will be compared with participants in these studies who had no medical problems after receiving Ultravist to learn more about the characteristics of people at higher risk.
Data will be from the year 1999 up to 2011. No visits or tests are required as part of this study.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - Patients of all age groups which were referred to any iodine-based contrast-enhanced procedure after administration of either Ultravist 300 mg I/mL or 370 mg I/mL.

Trial summary

Enrollment Goal
152233
Trial Dates
June 2022 - October 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Bayer​Wuppertal, 42096, Germany

Primary Outcome

  • Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex
    Cases (based on MedDRA version 21.0): Patients with any typical and unequivocal hypersensitivity reaction: anaphylactoid shock, angioedema, asthma, bronchospasm, conjunctivitis, cough, dysphagia, dyspnea, edema mucosal, erythema/exanthema/rash, hoarseness, lacrimation, laryngeal/pharyngeal/face edema, laryngeal/pharyngeal spasm, nasal stuffiness, pruritus/itching, respiratory arrest, rhinitis, sneezing, stridor, swelling (eyes/face), throat irritation, tongue edema, urticaria/hives/blisters, wheezing.
    date_rangeTime Frame:
    ≤1 hour after contrast administration
  • Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different race
    date_rangeTime Frame:
    ≤1 hour after contrast administration
  • Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients from different countries/regions
    date_rangeTime Frame:
    ≤1 hour after contrast administration

Secondary Outcome

  • Differences regarding specific HSRs in patients with different sex
    date_rangeTime Frame:
    ≤1 hour after contrast administration
  • Differences regarding specific HSRs in patients with different race
    date_rangeTime Frame:
    ≤1 hour after contrast administration
  • Differences regarding specific HSRs in patients from different countries/regions
    date_rangeTime Frame:
    ≤1 hour after contrast administration

Trial design

Safety profile of Ultravist in patients with different sexes, races and from different countries/regions
Trial Type
Observational
Intervention Type
Diagnostic Test
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A