Clinical trial NCT05428397: 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
Official title: Safety Profile of Ultravist in Patients With Different Sexes, Races and From Different Countries/Regions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Enhanced X-ray Based Examination
Keywords: Hypersensitivity reaction
CT
Angiography
Contrast enhancement
Computed tomography
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 152233
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this integrated analysis, the data of four company sponsored non-interventional studies with Ultravist in contrast-enhanced X-ray examination have been pooled. This pool consists of studies 'PMS I', 'IMAGE', 'TRUST', 'Ultravist in CT'.The total data pool consists of 152,233 patients. The timeframe of these 4 studies is from 6/1999 until 11/2011. The study utilizes data collected as a part of clinical practice across 37 countries and including Europe (mostly Germany and Spain), Asia (mostly China and South Korea) and USA. It will not include any new and not yet published data. Patients of all ages, both sexes, multiple races and across various health conditions/indications are represented in this pooled database.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex
timeFrame: ≤1 hour after contrast administration
measure: Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different race
timeFrame: ≤1 hour after contrast administration
measure: Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients from different countries/regions
timeFrame: ≤1 hour after contrast administration
Secondary outcomes:
measure: Differences regarding specific HSRs in patients with different sex
timeFrame: ≤1 hour after contrast administration
measure: Differences regarding specific HSRs in patients with different race
timeFrame: ≤1 hour after contrast administration
measure: Differences regarding specific HSRs in patients from different countries/regions
timeFrame: ≤1 hour after contrast administration
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: Bayer
Study officials:
References:
citation: Palkowitsch P, Lengsfeld P, Stauch K, Heinsohn C, Kwon ST, Zhang SX, Liang CH. Safety and diagnostic image quality of iopromide: results of a large non-interventional observational study of European and Asian patients (IMAGE). Acta Radiol. 2012 Mar 1;53(2):179-86. doi: 10.1258/ar.2011.110359. Epub 2011 Dec 19.
citation: Chen W, Mempel M, Schober W, Behrendt H, Ring J. Gender difference, sex hormones, and immediate type hypersensitivity reactions. Allergy. 2008 Nov;63(11):1418-27. doi: 10.1111/j.1398-9995.2008.01880.x.
citation: Chen JY, Liu Y, Zhou YL, Tan N, Zhang B, Chen PY, Chen LB. Safety and tolerability of iopromide in patients undergoing cardiac catheterization: real-world multicenter experience with 17,513 patients from the TRUST trial. Int J Cardiovasc Imaging. 2015 Oct;31(7):1281-91. doi: 10.1007/s10554-015-0688-9. Epub 2015 Jun 10.
citation: Kopp AF, Mortele KJ, Cho YD, Palkowitsch P, Bettmann MA, Claussen CD. Prevalence of acute reactions to iopromide: postmarketing surveillance study of 74,717 patients. Acta Radiol. 2008 Oct;49(8):902-11. doi: 10.1080/02841850802282811.