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
  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:


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 April 16, 2014