Effect of Metal Skin Sensitivity on Restenosis After Stent Implantation

Coronary Stent Restenosis Clinical Trial

Official title:

Rate of Metal Skin Allergy in Cohorts of Patients With and Without Coronary Stent Restenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00226525
• Other study ID #: 20-03.09.04-HMO-CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: July 10, 2005
• Last updated: November 6, 2006
• Start date: February 2005
• Est. completion date: August 2006

Study information

• Verified date: September 2006
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Stent Restenosis

Intervention

Procedure:
• skin sensitivity test

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of skin delayed type hypersensitivity to metals among patients with restenosis and without restenosis