search
Back to results

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

Primary Purpose

Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Skin tests with radiocontrast media
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypersensitivity focused on measuring Contrast media skin test, Skin test, hypersensitivity, contrast media

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Healthy controls

Patients with immediate reactions

Arm Description

Outcomes

Primary Outcome Measures

Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media

Secondary Outcome Measures

Blood in vitro test from patients with a history of immediate reactions to radiocontrast media

Full Information

First Posted
January 8, 2009
Last Updated
November 17, 2010
Sponsor
Chulalongkorn University
search

1. Study Identification

Unique Protocol Identification Number
NCT00819494
Brief Title
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
Official Title
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity
Keywords
Contrast media skin test, Skin test, hypersensitivity, contrast media

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Sham Comparator
Arm Title
Patients with immediate reactions
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Skin tests with radiocontrast media
Intervention Description
Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Blood in vitro test from patients with a history of immediate reactions to radiocontrast media
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with history of immediate hypersensitivity reactions to iodinated contrast media 15-70 years of age Exclusion Criteria: On antihistamine/ cannot discontinue antihistamine before the test Having asthma exacerbation Being pregnant Suffering from severe systemic disease/ in bad health
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiat Ruxrungtham, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs