Foramen Ovale, Patent Clinical Trial
— INSPIREOfficial title:
Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder; a RandomizEd Trial.
Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes in selected patients. The devices used for the specific purpose contain and release nickel, which is considered as the most allergen metal in nature. Skin patch tests are considered as gold-standard for documenting nickel allergy. While the allergic contact dermatitis induced by nickel is well described, literature is inadequate on explaining the effect of nickel release on the clinical manifestations of patients implanted with such devices. Our prospective, randomized, blinded trial will try to investigate the above by performing nickel skin patch tests to all patients, 14 days before and 90 days after the implantation. During follow-up, clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - Age: at least 14 years old - Well-documented indication for percutaneous PFO closure Exclusion Criteria: - Severe periprocedural complications (death, device embolization, major bleeding, etc) - Patient's refusal to participation |
Country | Name | City | State |
---|---|---|---|
Greece | First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens | Athens | Attica |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens |
Greece,
Ahlstrom MG, Thyssen JP, Wennervaldt M, Menne T, Johansen JD. Nickel allergy and allergic contact dermatitis: A clinical review of immunology, epidemiology, exposure, and treatment. Contact Dermatitis. 2019 Oct;81(4):227-241. doi: 10.1111/cod.13327. Epub — View Citation
Apostolos A, Drakopoulou M, Toutouzas K. New migraines after atrial septal defect occlusion. Is the nickel hypersensitivity the start of everything? Med Hypotheses. 2021 Jan;146:110442. doi: 10.1016/j.mehy.2020.110442. Epub 2020 Nov 30. No abstract availa — View Citation
Prestipino F, Pragliola C, Lusini M, Chello M. Nickel allergy induced systemic reaction to an intracardiac amplatzer device. J Card Surg. 2014 May;29(3):349-50. doi: 10.1111/jocs.12331. — View Citation
Schalock PC, Crawford G, Nedorost S, Scheinman PL, Atwater AR, Mowad C, Brod B, Ehrlich A, Watsky KL, Sasseville D, Silvestri D, Worobec SM, Elliott JF, Honari G, Powell DL, Taylor J, DeKoven J. Patch Testing for Evaluation of Hypersensitivity to Implante — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite outcome including patient-reported chest pain, palpitations, headaches, and rash. | Clinical signs and symptoms during the first 90 days after the procedure will be evaluated through a questionnaire. | The first 90 days after the procedure | |
Secondary | The nickel patch tests' results change after Amplatzer Device implantation | Investigating the number of patients received Amplatzer device, who developed nickel sensitization. | The first 90 days after the procedure | |
Secondary | The nickel patch tests' results change after Gore Device implantation | Investigating the number of patients received Gore device, who developed nickel sensitization. | The first 90 days after the procedure | |
Secondary | Residual interatrial leakage | Evaluation of residual interatrial leakage, by performing transthoracic echocardiography | 90 days after the procedure | |
Secondary | Rest allergens skin patch test results' change | The possible change (either as continuous or dichotomous outcome) of rest allergen skin patch test, after the device implantation | 90 days after the procedure | |
Secondary | Nickel patch test results' change | The possible change (either as continuous or dichotomous outcome) of nickel skin patch test, after the device implantation | 90 days after the procedure |
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