NCT00819494

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 18, 2010

Status Verified

November 1, 2010

Enrollment Period

4 months

First QC Date

January 8, 2009

Last Update Submit

November 17, 2010

Conditions

Hypersensitivity

Keywords

Contrast media skin testSkin testhypersensitivitycontrast media

Outcome Measures

Primary Outcomes (1)

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

    5 months

Secondary Outcomes (1)

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

    5 months

Study Arms (2)

Healthy controls

SHAM COMPARATOR
Procedure: Skin tests with radiocontrast media

Patients with immediate reactions

ACTIVE COMPARATOR
Procedure: Skin tests with radiocontrast media

Interventions

Skin tests with radiocontrast mediaPROCEDURE

Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media

Healthy controlsPatients with immediate reactions

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with history of immediate hypersensitivity reactions to iodinated contrast media
  • years of age

You may not qualify if:

  • On antihistamine/ cannot discontinue antihistamine before the test
  • Having asthma exacerbation
  • Being pregnant
  • Suffering from severe systemic disease/ in bad health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Skin TestsContrast Media

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesDiagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Kiat Ruxrungtham, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

November 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 18, 2010

Record last verified: 2010-11

Locations

TH(1)