Metal AllergyRESTALLNCT03588962
Metal Allergy In-Stent Restenosis Study
A study testing In-stent restenosis in people with Metal Allergy and Contact Allergy, run by Silesian Centre for Heart Diseases.
Trial summary
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metal Allergy, Contact Allergy, Restenoses, Coronary
- What is being tested?
- In-stent restenosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 31 Dec 2020
- 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
- angiographically proven in-stent restenosis after technically correct implantation
- technically correctly implanted stent
Who cannot join
- autoimmune diseases (e.g., rheumatoid arthritis)
- immunodeficiency syndromes (e.g., HIV infection)
- chronic use of immunosuppressive drugs and/or corticosteroids
- skin lesions that may attenuate the reading of skin tests
- previous coronary artery bypass surgery (in subgroup 1) or planned coronary artery bypass surgery (in subgroup 2)
- any surgical procedure with metal implants (in the past or planned within 12 months of observation)
About this study
Official title: RESTenosis in Patients With Contact ALLergy to Metals Zabrze Study
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation. There are multiple factors causing restenosis, which can be divided into two major groups: first vessel-dependent (based on the vessel's tortuosity, dimensions and lesion's calcification, all leading to suboptimal stent expansion), and second dependent on the inflammatory processes caused by the intervention. Study objectives is the analysis of the possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence. The angiographic results of stent implantation, and in-stent restenosis will be assessed independently by two skilled interventional cardiologists, and in case of their discrepant opinions, the decision will be made on the basis of the third cardiologist. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.
Read the detailed description
Introduction:
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation. There are multiple factors causing restenosis, which can be divided into two major groups: first vessel-dependent (based on the vessel's tortuosity, dimensions and lesion's calcification, all leading to suboptimal stent expansion), and second dependent on the inflammatory processes caused by the intervention. Although the proper stent expansion depends mostly on the cardiologist's manual dexterity, the inflammation development does totally not depend on the operator. The allergic reactions to metals are likely to be one of the underlying causes of inflammation. Among the most prevalent allergens, cobalt, chromium, nickel, and tungsten used as the stent materials are causing the most intensive contact allergic reaction. The allergic process induced by the aforementioned metals belongs to type IV contact allergy (T-cell mediated). Stent implantation results in life-long contact with metal, thus in allergic patients, it is likely to develop local reactions leading to in-stent restenosis. Up to date, there have been approximately one thousand in-stent restenosis cases documented in patients with confirmed contact allergy to stent metals.
Study objectives:
Analysis of the possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence.
Materials and methods:
The study will consist of two arms:
First arm: Patch tests for the metals used in stent production will be applicated in the patients with angiographically proven in-stent restenosis developed after technically correct implantation.
Second arm: In patients with (technically correctly) implanted stent, patch tests will be applicated to identify cases with contact allergy. The patients will then be monitored for a 6-12 months follow-up period in purpose of evaluating the dependance between in-stent restenosis and contact allergy.
The angiographic results of stent implantation, and in-stent restenosis will be assessed independently by two skilled interventional cardiologists, and in case of their discrepant opinions, the decision will be made on the basis of the third cardiologist.
The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.
- Conditions
- Metal Allergy, Contact Allergy, Restenoses, Coronary, In-stent Restenosis, Coronary Artery Disease
- Being tested
- In-stent restenosis
- Keywords
- allergy to metals, restenosis, in-stent restenosis, coronary artery disease
- Medical subject headings
- Dermatitis, Allergic Contact, Coronary Restenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-stent restenosisBiological
Patch tests for the metals applicated in each of the patients
| Study group | Role | What they receive |
|---|---|---|
| Metal allergy driven restenosis | Experimental | Patients with angiographically proven in-stent restenosis developed after technically correct implantation. Patch tests for the metals used in stent production will be applicated. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards. Possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence. Receives: Biological: In-stent restenosis |
| Looking for allergic restenosis | Placebo comparator | Patients with (technically correctly) implanted stent. Patch tests will be applicated to identify cases with contact allergy. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.The patients will then be monitored for a 12 months follow-up period in purpose of evaluating the dependance between in-stent restenosis and contact allergy. Possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence. Receives: Biological: In-stent restenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
In-stent restenosis, acute myocardial infarction (AMI), death, cardiovascular (CV) death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metal AllergyStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Gasior, Silesian Centre for Heart Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588962
- Sponsor's protocol ID
- RESTALL Zabrze Study
- Acronym
- RESTALL
- Status last verified
- Jul 2018
- First submitted
- 18 Mar 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTenosis in Patients With Contact ALLergy to Metals Zabrze Study
- ClinicalTrials.gov ID
- NCT03588962
- Acronym / sponsor ID
- RESTALL / RESTALL Zabrze Study
- Conditions
- Metal Allergy, Contact Allergy, Restenoses, Coronary, In-stent Restenosis, Coronary Artery Disease
- Keywords
- allergy to metals, restenosis, in-stent restenosis, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Jul 2018 (actual)
- 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.
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation. There are multiple factors causing restenosis, which can be divided into two major groups: first vessel-dependent (based on the vessel's tortuosity, dimensions and lesion's calcification, all leading to suboptimal stent expansion), and second dependent on the inflammatory processes caused by the intervention. Study objectives is the analysis of the possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence. The angiographic results of stent implantation, and in-stent restenosis will be assessed independently by two skilled interventional cardiologists, and in case of their discrepant opinions, the decision will be made on the basis of the third cardiologist. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.
Detailed description
Introduction:
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation. There are multiple factors causing restenosis, which can be divided into two major groups: first vessel-dependent (based on the vessel's tortuosity, dimensions and lesion's calcification, all leading to suboptimal stent expansion), and second dependent on the inflammatory processes caused by the intervention. Although the proper stent expansion depends mostly on the cardiologist's manual dexterity, the inflammation development does totally not depend on the operator. The allergic reactions to metals are likely to be one of the underlying causes of inflammation. Among the most prevalent allergens, cobalt, chromium, nickel, and tungsten used as the stent materials are causing the most intensive contact allergic reaction. The allergic process induced by the aforementioned metals belongs to type IV contact allergy (T-cell mediated). Stent implantation results in life-long contact with metal, thus in allergic patients, it is likely to develop local reactions leading to in-stent restenosis. Up to date, there have been approximately one thousand in-stent restenosis cases documented in patients with confirmed contact allergy to stent metals.
Study objectives:
Analysis of the possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence.
Materials and methods:
The study will consist of two arms:
First arm: Patch tests for the metals used in stent production will be applicated in the patients with angiographically proven in-stent restenosis developed after technically correct implantation.
Second arm: In patients with (technically correctly) implanted stent, patch tests will be applicated to identify cases with contact allergy. The patients will then be monitored for a 6-12 months follow-up period in purpose of evaluating the dependance between in-stent restenosis and contact allergy.
The angiographic results of stent implantation, and in-stent restenosis will be assessed independently by two skilled interventional cardiologists, and in case of their discrepant opinions, the decision will be made on the basis of the third cardiologist.
The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal allergy driven restenosis | Experimental | Biological: In-stent restenosisPatients with angiographically proven in-stent restenosis developed after technically correct implantation. Patch tests for the metals used in stent production will be applicated. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards. Possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence. |
| Looking for allergic restenosis | Placebo comparator | Biological: In-stent restenosisPatients with (technically correctly) implanted stent. Patch tests will be applicated to identify cases with contact allergy. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.The patients will then be monitored for a 12 months follow-up period in purpose of evaluating the dependance between in-stent restenosis and contact allergy. Possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- angiographically proven in-stent restenosis after technically correct implantation
- technically correctly implanted stent
Key exclusion criteria (6 listed)
- autoimmune diseases (e.g., rheumatoid arthritis)
- immunodeficiency syndromes (e.g., HIV infection)
- chronic use of immunosuppressive drugs and/or corticosteroids
- skin lesions that may attenuate the reading of skin tests
- previous coronary artery bypass surgery (in subgroup 1) or planned coronary artery bypass surgery (in subgroup 2)
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 |
|---|---|---|
| In-stent restenosisPatch tests for the metals applicated in each of the patients | Biological | Looking for allergic restenosis, Metal allergy driven restenosis |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 12 months
In-stent restenosis, acute myocardial infarction (AMI), death, cardiovascular (CV) death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing In-stent restenosis in people with Metal Allergy and Contact Allergy, run by Silesian Centre for Heart Diseases.
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 2 inclusion and 6 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Major Adverse Cardiovascular Events (MACE) (time frame: 12 months). 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 17 Jul 2018.