Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery

NCT06275399 | Recruiting

• 1 other identifier: INTERFORCE
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Coronary Syndrome; Atherosclerosis

Keywords

Optical Coherence Tomography; vFFR; Shear Rate; Impedance aggregometry; Shear stress; Proteomic; Metabolomic; Computational fluid dynamics; Prothrombotic platelet; Vulnerable plaque

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

  Baseline

• Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery

  Baseline

• 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

• Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers

  Baseline

• Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity

  Baseline

Study Arms (1)

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.

Diagnostic Test: OCT examination; Diagnostic Test: Blood sampling; Diagnostic Test: Assessment of vFFR and shear stress parameters

Interventions

OCT examination DIAGNOSTIC_TEST

OCT examination for precise evaluation of plaque morphology within the coronary stenosis.

Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging

Blood sampling DIAGNOSTIC_TEST

Blood sampling directly from coronary artery (proximal and distal segment) arteries

Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging

Assessment of vFFR and shear stress parameters DIAGNOSTIC_TEST

The procedure is based on non-invasive assessment of vFFR and shear stress parameters with dedicated software, deriving parameters directly from coronary angiography with the calculation based on the computational fluid dynamics

Patients with chronic coronary syndrome and coronary stenosis (30% - 90%) amenable to OCT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be enrolled presenting with chronic coronary syndrome and angiographically confirmed coronary stenosis (30% - 90%) amenable to OCT imaging (according to the operator's judgment).

You may qualify if:

• Chronic coronary syndrome
• Angiographically confirmed coronary stenosis (30% - 90%)
• Amenable to OCT imaging

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• National Science Centre, Poland: collaborator
• University College, London: collaborator
• Queen Mary University of London: collaborator

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Mariusz Tomaniak

CONTACT

+48 22 5991951; mariusz.tomaniak@wum.edu.pl

Adrian Bednarek

CONTACT

adikbednarek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tomaniak Mariusz MD PhD Assoc. Prof.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 23, 2024
• Study Start: July 21, 2023
• Primary Completion: July 21, 2025
• Study Completion (Estimated): July 21, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)