Effect of Metal Skin Sensitivity on Restenosis After Sten... | NCT00226525

Studies
Effect of Metal Skin Sensitivity on Restenosis After Stent Implantation

NCT00226525

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Nov 7, 2006Estimated

Enrollment

150

Phase

Not Applicable

Conditions

Coronary Stent Restenosis

Interventions

skin sensitivity test

Countries

Israel

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

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Not provided

Completion Date

Aug 2006

First Submitted Date

Jul 10, 2005

First Submission Date that Met QC Criteria

Sep 26, 2005

First Posted Date

Sep 27, 2005Estimated

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 6, 2006

Last Update Posted Date

Nov 7, 2006Estimated

Description Module

Brief Summary

This trial is intended to find wether there is a connection between allergy to metals and reooclusion of stents in the coronary arteries

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

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
skin sensitivity test	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of skin delayed type hypersensitivity to metals among patients with restenosis and without restenosis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with 2 cardiac catheterization in one years time and in the first one stent implantation

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronen Durst, MD	Cardiology Department Hadassah Medical Center Jerusalem Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Center		Jerusalem			Israel