Metal Allergy In-Stent Restenosis Study (RESTALL)
Metal Allergy, Contact Allergy, Restenoses, Coronary
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
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
Experimental
Placebo Comparator
Metal allergy driven restenosis
Looking for allergic restenosis
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.