NCT06275399 Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery
| NCT ID | NCT06275399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Warsaw |
| Condition | Chronic Coronary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 105 participants |
| Start Date | 2023-07-21 |
| Primary Completion | 2025-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 105 participants in total. It began in 2023-07-21 with a primary completion date of 2025-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Chronic coronary syndrome * Angiographically confirmed coronary stenosis (30% - 90%) * Amenable to OCT imaging Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06275399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06275399 currently recruiting?
Yes, NCT06275399 is actively recruiting participants. Contact the research team at mariusz.tomaniak@wum.edu.pl for enrollment information.
Where is the NCT06275399 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06275399 clinical trial?
NCT06275399 is sponsored by Medical University of Warsaw. The trial plans to enroll 105 participants.