Coronary Stent RestenosisNCT00226525
Effect of Metal Skin Sensitivity on Restenosis After Stent Implantation
A study testing skin sensitivity test in people with Coronary Stent Restenosis, run by Hadassah Medical Organization at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stent Restenosis
- What is being tested?
- skin sensitivity test
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2005to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with 2 cardiac catheterization in one years time and in the first one stent implantation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rate of Metal Skin Allergy in Cohorts of Patients With and Without Coronary Stent Restenosis
This trial is intended to find wether there is a connection between allergy to metals and reooclusion of stents in the coronary arteries
- Conditions
- Coronary Stent Restenosis
- Being tested
- skin sensitivity test
- Keywords
- Restenosis, skin metal allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin sensitivity testProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of skin delayed type hypersensitivity to metals among patients with restenosis and without restenosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Stent RestenosisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ronen Durst, MD, Principal investigator, Cardiology Department Hadassah Medical Center Jerusalem Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226525
- Sponsor's protocol ID
- 20-03.09.04-HMO-CTIL
- Status last verified
- Sep 2006
- First submitted
- 10 Jul 2005
- Last updated
- 7 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Metal Skin Allergy in Cohorts of Patients With and Without Coronary Stent Restenosis
- ClinicalTrials.gov ID
- NCT00226525
- Acronym / sponsor ID
- 20-03.09.04-HMO-CTIL
- Conditions
- Coronary Stent Restenosis
- Keywords
- Restenosis, skin metal allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Aug 2006
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is intended to find wether there is a connection between allergy to metals and reooclusion of stents in the coronary arteries
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with 2 cardiac catheterization in one years time and in the first one stent implantation
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin sensitivity test | Procedure or surgery | – |
Primary outcome
The rate of skin delayed type hypersensitivity to metals among patients with restenosis and without restenosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronen Durst, MD principal investigator
Cardiology Department Hadassah Medical Center Jerusalem Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin sensitivity test in people with Coronary Stent Restenosis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of skin delayed type hypersensitivity to metals among patients with restenosis and without restenosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2006.