In-stent Restenosis Clinical Trial
Official title:
Risk Factors and Novel Biomarkers Associated With In-stent Restenosis After Percutaneous Coronary Intervention
To study the relation between ISR and neutrophil-to-lymphocyte ratio (NLR), novel biomarkers (high-sensitivity CRP (hs-CRP), bone morphogenetic protein-2 (BMP-2) and other risk factors (age, sex, smoking, hypertension, diabetes, obesity, chronic kidney disease (CKD; creatinine clearance).
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | February 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients with previously implanted 3rd generation DES (Sirolimus, Biolimus, Everolimus, Zotarolimus), whatever the duration since implantation or the setting of implantation or the number of implanted stents, and who are presenting to our institute along the coming two years for CA±PCI because of recurrent chest pain with suspicious of ISR or other newly developed lesions. Exclusion Criteria: - • Previous CABG - ACS within the last 2ms before the index CA for those undergoing assessment of hs-CRP & BMP-2 - Heart failure with reduced EF<40% - Severe liver or kidney disease - Autoimmune, inflammatory, or malignant diseases - Non-available previous PCI CD & report |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Assimes TL, Roberts R. Genetics: Implications for Prevention and Management of Coronary Artery Disease. J Am Coll Cardiol. 2016 Dec 27;68(25):2797-2818. doi: 10.1016/j.jacc.2016.10.039. — View Citation
Csiszar A, Smith KE, Koller A, Kaley G, Edwards JG, Ungvari Z. Regulation of bone morphogenetic protein-2 expression in endothelial cells: role of nuclear factor-kappaB activation by tumor necrosis factor-alpha, H2O2, and high intravascular pressure. Circulation. 2005 May 10;111(18):2364-72. doi: 10.1161/01.CIR.0000164201.40634.1D. Epub 2005 Apr 25. — View Citation
Kitoga M, Pasquet A, Preumont V, Kefer J, Hermans MP, Vanoverschelde JL, Buysschaert M. Coronary in-stent restenosis in diabetic patients after implantation of sirolimus or paclitaxel drug-eluting coronary stents. Diabetes Metab. 2008 Feb;34(1):62-7. doi: 10.1016/j.diabet.2007.09.002. — View Citation
Mauri L, Silbaugh TS, Wolf RE, Zelevinsky K, Lovett A, Zhou Z, Resnic FS, Normand SL. Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts. Circulation. 2008 Oct 28;118(18):1817-27. doi: 10.1161/CIRCULATIONAHA.108.781377. Epub 2008 Oct 13. Erratum In: Circulation. 2010 Jul 20;122(3):e398. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Role of novel biomarkers (high-sensitivity CRP (hs-CRP), bone morphogenetic protein-2 (BMP-2) associated with in-stent restenosis after percutaneous coronary intervention | Analysis of high-sensitivity CRP (hs-CRP), bone morphogenetic protein-2 (BMP-2) and incidence of ISR after percutaneous coronary intervention | Baseline |
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