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

This study has been completed.

First Received: January 8, 2009 Last Updated: March 6, 2009 History of Changes

Sponsored by:	Chulalongkorn University
Information provided by:	Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00819494

Purpose

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

Condition	Intervention
Hypersensitivity	Procedure: Skin tests with radiocontrast media

MedlinePlus related topics: Allergy

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Blood in vitro test from patients with a history of immediate reactions to radiocontrast media [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment:	63
Study Start Date:	November 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Healthy controls: Sham Comparator	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
Patients with immediate reactions: Active Comparator	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

Eligibility

Criteria

Inclusion Criteria:

Patients with history of immediate hypersensitivity reactions to iodinated contrast media
15-70 years of age

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819494

Locations

Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330

Sponsors and Collaborators

Chulalongkorn University

Investigators

Principal Investigator:

Kiat Ruxrungtham, MD

Chulalongkorn University

More Information

No publications provided

Responsible Party:	Chulalongkorn University ( Kiat Ruxrungtham, MD )
Study ID Numbers:	Chula-ARC 003/08
Study First Received:	January 8, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00819494 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:

Contrast media skin test
Skin test
hypersensitivity
contrast media

Study placed in the following topic categories:

Hypersensitivity
Hypersensitivity, Immediate

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 06, 2009