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

NCT06498219 | Recruiting

• 1 other identifier: 9025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contrast Sensitivity

Keywords

Contrast Sensitivity; Iodinated contrast products; Allergic immunological mechanisms; Allergy

Outcome Measures

Primary Outcomes (1)

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

  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) .

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major subject (≥18 years old) 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Pneumologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Carine METZ-FAVRE, MD

CONTACT

33 3 69 55 06 84; carine.favre-metz@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 12, 2024
• Study Start: December 21, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

FR (1)