Optimization of the Skin Test Procedure With Iodinated Contrast Products for Certain Patients Suspected of Immediate Hypersensitivity

Hypersensitivity to iodinated contrast products (ICP) affects 1 to 3% of injected patients. These reactions require an allergological assessment with skin tests in order to distinguish allergic immunological mechanisms from other non-specific mechanisms. Current recommendations recommend carrying out prick tests followed by intradermal reactions up to a 10th dilution. However, undiluted IDRs are carried out by several teams under certain conditions, without this having been validated. Experience tends to show that these IDRs are relevant in certain patients to make the diagnosis without risk.

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Key information

Conditions

Contrast Sensitivity Hypersensitivity Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pneumologie - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Carine METZ-FAVRE, MD

CONTACT

[email protected]

33 3 69 55 06 84

Carine METZ-FAVRE, MD

PRINCIPAL_INVESTIGATOR

Charlotte HURSON, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Major subject (≥18 years old)
Subject treated in the allergology department in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to ICPs and having had at least one undiluted intradermal reaction to one or more ICPs.
Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

Exclusion criteria

Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

Treatment and study plan

Primary outcomes

Retrospective study of the relevance of performing pure intradermal reactions to iodinated contrast products (ICP) after obtaining a pure negative prick test.

Time frame: Files analyzed retrospectively cover the period from June 1, 2020 to July 3, 2023.

This retrospective study concerns patients treated at the Strasbourg University Hospital in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to (ICP) and having had at least one undiluted intradermal reaction to one or more (ICP) .

Study contacts

Contact information is provided by the study sponsor or research team.

Carine METZ-FAVRE, MD

CONTACT

[email protected]

33 3 69 55 06 84

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: OPT-TC-PCI

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 12, 2024
Registry last updated: Jul 12, 2024

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

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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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