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Effect of Metal Skin Sensitivity on Restenosis After Stent Implantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Hadassah Medical Organization.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00226525
First received: July 10, 2005
Last updated: November 6, 2006
Last verified: September 2006
History of Changes
  Purpose

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


Condition Intervention
Coronary Stent Restenosis
 Procedure: skin sensitivity test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Rate of Metal Skin Allergy in Cohorts of Patients With and Without Coronary Stent Restenosis

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • The rate of skin delayed type hypersensitivity to metals among patients with restenosis and without restenosis

Estimated Enrollment: 150
Study Start Date: February 2005
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226525

Locations
Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ronen Durst, MD Cardiology Department Hadassah Medical Center Jerusalem Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226525     History of Changes
Other Study ID Numbers: 20-03.09.04-HMO-CTIL
Study First Received: July 10, 2005
Last Updated: November 6, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Restenosis, skin metal allergy

ClinicalTrials.gov processed this record on June 18, 2013