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Metal Allergy In-Stent Restenosis Study (RESTALL)

Primary Purpose

Metal Allergy, Contact Allergy, Restenoses, Coronary

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
In-stent restenosis
Sponsored by
Silesian Centre for Heart Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metal Allergy focused on measuring allergy to metals, restenosis, in-stent restenosis, coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • angiographically proven in-stent restenosis after technically correct implantation
  • technically correctly implanted stent

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Metal allergy driven restenosis

    Looking for allergic restenosis

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Major Adverse Cardiovascular Events (MACE)
    In-stent restenosis, acute myocardial infarction (AMI), death, cardiovascular (CV) death

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2018
    Last Updated
    July 15, 2018
    Sponsor
    Silesian Centre for Heart Diseases
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03588962
    Brief Title
    Metal Allergy In-Stent Restenosis Study
    Acronym
    RESTALL
    Official Title
    RESTenosis in Patients With Contact ALLergy to Metals Zabrze Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    April 1, 2019 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Silesian Centre for Heart Diseases

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metal Allergy, Contact Allergy, Restenoses, Coronary, In-stent Restenosis, Coronary Artery Disease
    Keywords
    allergy to metals, restenosis, in-stent restenosis, coronary artery disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Metal allergy driven restenosis
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Looking for allergic restenosis
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    In-stent restenosis
    Intervention Description
    Patch tests for the metals applicated in each of the patients
    Primary Outcome Measure Information:
    Title
    Major Adverse Cardiovascular Events (MACE)
    Description
    In-stent restenosis, acute myocardial infarction (AMI), death, cardiovascular (CV) death
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: angiographically proven in-stent restenosis after technically correct implantation technically correctly implanted stent Exclusion Criteria: 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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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