Contrast Enhanced X-ray Based ExaminationNCT05428397

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

An observational study of Contrast Enhanced X-ray Based Examination, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Contrast Enhanced X-ray Based Examination
What is being tested?: Iopromide (Ultravist, BAY86-4877)
How many people: 152,233 participants
Where: 1 siteGermany
Study dates: 30 Jun 2022to 28 Oct 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Bayer
Wuppertal, 42096

Other trials in Germany

About this study

Official title: Safety Profile of Ultravist in Patients With Different Sexes, Races and From Different Countries/Regions

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.

Conditions: Contrast Enhanced X-ray Based Examination
Being tested: Iopromide (Ultravist, BAY86-4877)
Keywords: Hypersensitivity reaction, CT, Angiography, Contrast enhancement, Computed tomography
Medical subject headings: Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iopromide (Ultravist, BAY86-4877)Diagnostic test
Also called BAY86-4877_Iopromide_IV_X-Ray/CT Diagnostic Agents
X-Ray/CT Diagnostic Imaging

Study groups in NCT05428397
Study group	Role	What they receive
Contrast enhanced X-ray based examination with Ultravist		Patients who received a contrast enhanced X-ray based examination with Ultravist for various clinical reasons and having experienced a hypersensitivity reaction. Receives: Diagnostic Test: Iopromide (Ultravist, BAY86-4877)
Control group		Patient who received contrast enhanced X-ray based examination with Ultravist for various indications who had not adverse event. Receives: Diagnostic Test: Iopromide (Ultravist, BAY86-4877)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: ≤1 hour after contrast administration
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different race
Measured: ≤1 hour after contrast administration
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients from different countries/regions
Measured: ≤1 hour after contrast administration

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202228 Oct 2022

First posted23 Jun 2022
Study start30 Jun 2022
Primary completion28 Oct 2022
Study completion28 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Contrast Enhanced X-ray Based ExaminationStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 152,233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05428397
Sponsor's protocol ID: 22133
Status last verified: Oct 2023
First submitted: 17 Jun 2022
Last updated: 10 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

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.
PubMed 22184683
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.
PubMed 18925878
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.
PubMed 26058857
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.
PubMed 18651252

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Profile of Ultravist in Patients With Different Sexes, Races and From Different Countries/Regions
ClinicalTrials.gov ID: NCT05428397
Acronym / sponsor ID: 22133
Conditions: Contrast Enhanced X-ray Based Examination
Keywords: Hypersensitivity reaction, CT, Angiography, Contrast enhancement, Computed tomography
Study type: Observational
Recruitment status: Completed
Enrolment: 152,233 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 30 Jun 2022 (actual)
Primary completion: 28 Oct 2022 (actual)
Study completion: 28 Oct 2022 (actual)
First posted: 23 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

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).

Data will be from the year 1999 up to 2011. No visits or tests are required as part of this study.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Contrast enhanced X-ray based examination with Ultravist	–	Diagnostic Test: Iopromide (Ultravist, BAY86-4877)Patients who received a contrast enhanced X-ray based examination with Ultravist for various clinical reasons and having experienced a hypersensitivity reaction.
Control group	–	Diagnostic Test: Iopromide (Ultravist, BAY86-4877)Patient who received contrast enhanced X-ray based examination with Ultravist for various indications who had not adverse event.

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Iopromide (Ultravist, BAY86-4877)Also: BAY86-4877_Iopromide_IV_X-Ray/CT Diagnostic AgentsX-Ray/CT Diagnostic Imaging	Diagnostic test	Contrast enhanced X-ray based examination with Ultravist, Control group

Primary outcome

Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex
Time frame: ≤1 hour after contrast administration
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.
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different race
Time frame: ≤1 hour after contrast administration
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients from different countries/regions
Time frame: ≤1 hour after contrast administration

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Background: PubMed 22184683Palkowitsch 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.
Background: PubMed 18925878Chen 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.
Background: PubMed 26058857Chen 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.
Results publication: PubMed 18651252Kopp 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.
Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Contrast Enhanced X-ray Based Examination, run by Bayer at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex (time frame: ≤1 hour after contrast administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05428397, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.