protocolSection identificationModule nctId: NCT06275399, orgStudyIdInfo id: INTERFORCE, briefTitle: Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery, acronym: INTERFORCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-21, primaryCompletionDateStruct date: 2025-07-21, completionDateStruct date: 2026-07-21, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, collaborators name: National Science Centre, Poland, collaborators name: University College, London, collaborators name: Queen Mary University of London, descriptionModule 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., conditionsModule conditions: Chronic Coronary Syndrome, conditions: Atherosclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: OCT examination, interventions name: Blood sampling, interventions name: Assessment of vFFR and shear stress parameters, outcomesModule primaryOutcomes 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., secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers, secondaryOutcomes measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes measure: Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery, secondaryOutcomes measure: Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery, secondaryOutcomes measure: Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes 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, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Warsaw, status: RECRUITING, city: Warsaw, state: Mazowieckie, zip: 02-097, country: Poland, contacts name: Mariusz Tomaniak, MD, PhD, Assoc. Prof., role: CONTACT, email: mariusz.tomaniak@wum.edu.pl, contacts name: Adrian Bednarek, role: CONTACT, email: adikbednarek@gmail.com, contacts name: Mariusz Tomaniak, MD, PhD, Assoc. Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False