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NCT00819494 Clinical Trial

Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media

Hypersensitivity Clinical Trial

Official title:
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00819494
Other study ID # Chula-ARC 003/08
Secondary ID
Status Completed
Phase N/A
First received January 8, 2009
Last updated November 17, 2010
Start date November 2008
Est. completion date March 2009

Study information
Verified date November 2010
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 70 Years
Eligibility Inclusion Criteria:

1. Patients with history of immediate hypersensitivity reactions to iodinated contrast media

2. 15-70 years of age

Exclusion Criteria:

1. On antihistamine/ cannot discontinue antihistamine before the test

2. Having asthma exacerbation

3. Being pregnant

4. Suffering from severe systemic disease/ in bad health

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Skin tests with radiocontrast media
Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media

Locations
Country Name City State
Thailand Faculty of Medicine, Chulalongkorn University Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media 5 months Yes
Secondary Blood in vitro test from patients with a history of immediate reactions to radiocontrast media 5 months No
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