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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00819494
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
Chulalongkorn University

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

Condition or disease Intervention/treatment
Hypersensitivity Procedure: Skin tests with radiocontrast media

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
Study Start Date : November 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Healthy controls 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
Active Comparator: Patients with immediate reactions 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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Blood in vitro test from patients with a history of immediate reactions to radiocontrast media [ Time Frame: 5 months ]


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819494


Locations
Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Kiat Ruxrungtham, MD Chulalongkorn University

Responsible Party: Jettanong Klaewsongkram, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00819494     History of Changes
Other Study ID Numbers: Chula-ARC 003/08
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010

Keywords provided by Chulalongkorn University:
Contrast media skin test
Skin test
hypersensitivity
contrast media

Additional relevant MeSH terms:
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases