Role of Skin Tests for the Diagnosis of Immediate Hyperse... | NCT00819494

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

NCT00819494

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Nov 18, 2010Estimated

Enrollment

63Actual

Phase

Not Applicable

Conditions

Hypersensitivity

Interventions

Skin tests with radiocontrast media

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 8, 2009

First Posted Date

Jan 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2010

Last Update Posted Date

Nov 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy controls	Sham Comparator		Procedure: Skin tests with radiocontrast media
Patients with immediate reactions	Active Comparator		Procedure: Skin tests with radiocontrast media

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skin tests with radiocontrast media	Procedure	Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Blood in vitro test from patients with a history of immediate reactions to radiocontrast media		5 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kiat Ruxrungtham, MD	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Chulalongkorn University		Bangkok		10330	Thailand

ID	Term
D006967	Hypersensitivity

ID	Term
D007154	Immune System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D012882	Skin Tests
D003287	Contrast Media

Ancestor Terms

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided