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

This study has been completed.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00819494
First received: January 8, 2009
Last updated: November 17, 2010
Last verified: November 2010
History of Changes
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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
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

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
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
  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: Jettanong Klaewsongkram, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00819494     History of Changes
Other Study ID Numbers: Chula-ARC 003/08
Study First Received: January 8, 2009
Last Updated: November 17, 2010
Health Authority: Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013