Actively Recruiting

Age: 18Years +
All Genders
ID06275399

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic coronary syndrome
  • Angiographically confirmed coronary stenosis (30% - 90%)
  • Amenable to OCT imaging
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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