Role of Novel Biomarkers Associated With In-stent Restenosis After Percutaneous Coronary Intervention

NCT06148441 | Unknown

• 1 other identifier: novel biomarkers and ISR
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

In-stent Restenosis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

bone morphogenetic protein-2 (BMP-2) DIAGNOSTIC_TEST

novel biomarkers associated with in-stent restenosis after percutaneous coronary intervention

Also known as: novel biomarkers (high-sensitivity CRP (hs-CRP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 28007143 BACKGROUND

• 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.

  PMID: 18852368 BACKGROUND

• 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.

  PMID: 18069029 BACKGROUND

• 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.

  PMID: 15851600 BACKGROUND

Central Study Contacts

Elhussein Ahmed Mohamed, Doctor

CONTACT

01006424580; elhusseinahmed21@gmail.com

Salah Eldin Sayed Atta Mohammed, Professor

CONTACT

01091318801; salah_atta@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11