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Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
This study is currently recruiting participants.
Verified by Chulalongkorn University, January 2009
Sponsored by: Chulalongkorn University
Information provided by: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00819494
  Purpose

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
U.S. FDA Resources
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 ]

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: May 2009
Estimated 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

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

Contacts
Contact: Thatchai Kampitak, MD 662-2564152 thatchai_k@yahoo.com
Contact: Jettanong Klaewsongkram, MD 662-2564152 jettanong.K@chula.ac.th

Locations
Thailand
Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Thatchai Kampitak, MD     662-2564152     thatchai_k@yahoo.com    
Contact: Jettanong Klaewsongkram, MD     662-2564152     jettanong.K@chula.ac.th    
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Kiat Ruxrungtham, MD Chulalongkorn University
  More Information

Responsible Party: Chulalongkorn University ( Kiat Ruxrungtham, MD )
Study ID Numbers: Chula-ARC 003/08
Study First Received: January 8, 2009
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00819494  
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:
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009