Actively Recruiting
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
Led by Medical University of Warsaw · Updated on 2024-02-23
105
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Medical University of Warsaw
Lead Sponsor
N
National Science Centre, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how the forces exerted by blood flow, called shear rate and shear stress, relate to blood markers indicating clotting tendencies in people with chronic coronary syndrome and coronary artery narrowing. This study aims to connect these biomechanical forces with plaque characteristics, vessel function, and platelet activity assessed through advanced imaging and blood tests. It is a prospective, single-center observational study involving 105 patients with confirmed coronary stenosis suitable for detailed imaging. Participants undergo several evaluations during angiography, including optical coherence tomography (OCT) to examine plaque details, computational fluid dynamics (CFD) to estimate shear forces and vessel function via vessel fractional flow reserve (vFFR), and blood sampling from coronary arteries to measure platelet activation and inflammatory biomarkers. Some patients will also have proteomic and metabolomic analyses. Comparisons are made between stenosed and non-stenosed vessels within the same individuals. During the study, participants have imaging and blood tests to assess plaque morphology, shear stress distribution, platelet reactivity, and biomarker levels. Researchers will analyze how these factors correlate, focusing on blood sampled both proximally and distally to the stenosis. The primary outcome measures the correlation between shear forces and platelet-derived microvesicles and extracellular vesicles. The study monitors these parameters at baseline, with no long-term treatment or follow-up specified.
CONDITIONS
Brief Title
Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic coronary syndrome
- Angiographically confirmed coronary stenosis (30% - 90%)
- Amenable to OCT imaging
You will not qualify if you...
- 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 43 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo angiography with OCT examination and blood sampling from the coronary artery to evaluate plaque morphology, shear stress parameters, platelet reactivity, and biomarker profiles.
1 visit (in-person)
Duration - Up to study completion
Participants are observed for associations between shear stress, plaque morphology, and biomarker profiles after initial diagnostic testing.
No additional visits required
Trial Site Locations
Total: 1 location
1
Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland, 02-097
Actively Recruiting
Research Team
M
Mariusz Tomaniak
A
Adrian Bednarek
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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