nctId: NCT06275399 id: INTERFORCE briefTitle: Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery acronym: INTERFORCE overallStatus: RECRUITING date: 2023-07-21 date: 2025-07-21 date: 2026-07-21 date: 2024-02-23 date: 2024-02-23 name: Medical University of Warsaw class: OTHER name: National Science Centre, Poland name: University College, London name: Queen Mary University of London briefSummary: The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery. conditions: Chronic Coronary Syndrome conditions: Atherosclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: OCT examination name: Blood sampling name: Assessment of vFFR and shear stress parameters measure: Correlation between the mean shear rate and shear stress values at the lesion's site and the concentration of pMVs and sEVs sampled in the distal segment of the artery. measure: Correlation between the shear stress measurements at the site of the lesion and the concentration of inflammatory biomarkers in the distal segment of the artery measure: Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of the pMVs and sEVs measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity measure: Concentrations of inflammatory biomarkers categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Platelet reactivity levels categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Concentrations of pMVs and sEVs categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Correlation between vFFR delta pressure and the delta platelet reactivity in stenosed artery compared to these gradients in a non-stenosed artery in the same patient measure: Correlation between vFFR delta pressure and the delta concentration of the pMVs and sEVs in stenosed artery compared to these gradients in a non-stenosed artery in the same patient measure: Correlation between vFFR delta pressure and the delta concentration of the inflammatory biomarkers in stenosed artery compared to these gradients in a non-stenosed artery in the same patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Warsaw status: RECRUITING city: Warsaw state: Mazowieckie zip: 02-097 country: Poland name: Mariusz Tomaniak, MD, PhD, Assoc. Prof. role: CONTACT email: mariusz.tomaniak@wum.edu.pl name: Adrian Bednarek role: CONTACT email: adikbednarek@gmail.com name: Mariusz Tomaniak, MD, PhD, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False