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
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Chronic coronary syndrome

• Angiographically confirmed coronary stenosis (30% - 90%)

• Amenable to OCT imaging

Locations
Other Locations
Poland
Medical University of Warsaw
RECRUITING
Warsaw
Contact Information
Primary
Mariusz Tomaniak
mariusz.tomaniak@wum.edu.pl
+48 22 5991951
Backup
Adrian Bednarek
adikbednarek@gmail.com
Time Frame
Start Date: 2023-07-21
Estimated Completion Date: 2026-07-21
Participants
Target number of participants: 105
Treatments
Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging
Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging. The groups will be assessed at the time of angiography with:~* OCT for 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 pMVs and sEVs as well as additional platelet activation 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) arteries. Shear rate/shear stress distribution and biomarkers profile will be compared between the stenotic vessel and the non-stenotic vessel (stenoses \<30%) in the same patient.
Related Therapeutic Areas
Sponsors
Collaborators: Queen Mary University of London, National Science Centre, Poland, University College, London
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov