Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275399
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-07
Brief Title:
Comprehensive Assessment of Morphometric Functional Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERFORCE
Brief Summary:
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
Detailed Description:
The biomechanical forces including shear rate and shear stress exerted by circulating blood on the coronary wall and on circulating blood elements have been reported to contribute to the processes of plaque destabilization and thrombosis Reliable estimation of shear shear rate and shear stress acting in vivo within the coronary artery has now become possible using imaging data and computational fluid dynamics techniques The changing microenvironment of the plaque has a crucial role in the biochemical processes involved in remodeling the plaque itself In this prospective single-center study a total of 105 patients will be enrolled presenting with chronic coronary syndrome and angiographically confirmed coronary stenosis 30 - 90 amenable to OCT imaging according to the operators judgment
The groups will be assessed at the time of angiography with
OCT examination for precise evaluation of plaque morphology within the coronary stenosis
Computational fluid dynamics with vFFR and estimation of value and distribution of shear rate and shear stress
Impedance aggregometry-based platelet reactivity
Single-particle high-resolution flow cytometry analysis of platelet-derived microvesicles and small extracellular vesicles sEVs as well as additional platelet activation P-selectin annexin-V and inflammatory biomarkers
Proteomic and metabolomic characterization - in the subset of patients Biomarker assessment will be done in the blood sampled directly from coronary artery proximal and distal segment
The groups will be assessed at the time of angiography with
OCT examination for precise evaluation of plaque morphology within the coronary stenosis
Computational fluid dynamics with vFFR and estimation of value and distribution of shear rate and shear stress
Impedance aggregometry-based platelet reactivity
Single-particle high-resolution flow cytometry analysis of platelet-derived microvesicles and small extracellular vesicles sEVs as well as additional platelet activation P-selectin annexin-V and inflammatory biomarkers
Proteomic and metabolomic characterization - in the subset of patients Biomarker assessment will be done in the blood sampled directly from coronary artery proximal and distal segment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None