Atherosclerosis Clinical Trial
— INTERFORCEOfficial title:
Comprehensive Assessment of Morphometric, Functional, Biomechanical, and Biological Interactions Between Atherosclerotic Plaque and Blood Platelets Within the Stenosed Coronary Artery in Vivo: a Prospective Study
NCT number | NCT06275399 |
Other study ID # | INTERFORCE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 21, 2023 |
Est. completion date | July 21, 2026 |
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.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | July 21, 2026 |
Est. primary completion date | July 21, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Chronic coronary syndrome - Angiographically confirmed coronary stenosis (30% - 90%) - Amenable to OCT imaging Exclusion Criteria: - Cardiogenic shock - ST-segment elevation or non-ST-segment elevation myocardial infarction - Active bleeding - Left main coronary artery disease - Multivessel disease - Lesions located at a distance =3 mm from the ostium of the vessel - Thrombocytopenia - Previous coronary artery bypass grafting - Previous coronary intervention with stent implantation or balloon angioplasty - Previous use of novel oral anticoagulants or vitamin K antagonists |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Warsaw | Warsaw | Mazowieckie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw | National Science Centre, Poland, Queen Mary University of London, University College, London |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline | ||
Secondary | 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 | Inflammatory biomarkers will include sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-a, PlGF, IL-6, IL-18, IL-10, CCL2 | Baseline | |
Secondary | Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery | Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests | Baseline | |
Secondary | 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 | Baseline | ||
Secondary | Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers | Inflammatory biomarkers will include: sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-a, PlGF, IL-6, IL-18, IL-10, CCL2 | Baseline | |
Secondary | Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity | Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests | Baseline | |
Secondary | 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 | Inflammatory biomarkers will include: sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-a, PlGF, IL-6, IL-18, IL-10, CCL2 | Baseline | |
Secondary | 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 | Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests | Baseline | |
Secondary | 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 | Baseline | ||
Secondary | Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery | Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests | Baseline | |
Secondary | Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery | Baseline | ||
Secondary | Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery | Inflammatory biomarkers will include: sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-a, PlGF, IL-6, IL-18, IL-10, CCL2 | Baseline | |
Secondary | 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 | Platelet reactivity will be defined as the area under the curve of aggregation units (AU) over time using impedance aggregometry with ADP, ASPI, and TRAP-6 tests | Baseline | |
Secondary | 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 | Baseline | ||
Secondary | 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 | Inflammatory biomarkers will include: sST2, sRAGE, sCD40L, sFlt-1, LIGHT, TNF-a, PlGF, IL-6, IL-18, IL-10, CCL2 | Baseline |
Status | Clinical Trial | Phase | |
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