Assessing interactions between atherosclerotic plaque and platelets in coronary arteries
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
This study is testing how the forces in coronary arteries affect blood clotting in patients with chronic coronary syndrome to better understand plaque behavior and improve treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT06275399 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between shear forces in coronary arteries and biomarkers of blood clotting in patients with chronic coronary syndrome. Utilizing advanced imaging techniques like optical coherence tomography (OCT) and computational fluid dynamics (CFD), the study will evaluate the biomechanical forces acting on atherosclerotic plaques and their potential role in thrombosis. A total of 105 patients with confirmed coronary stenosis will undergo assessments including OCT imaging, vessel fractional flow reserve (vFFR) analysis, and blood sampling for platelet activation markers. The goal is to enhance understanding of plaque behavior and its implications for patient management.
Who should consider this trial
Good fit: Ideal candidates include patients with chronic coronary syndrome and angiographically confirmed coronary stenosis between 30% and 90% who are suitable for OCT imaging.
Not a fit: Patients with acute coronary syndromes, significant comorbidities, or prior interventions that affect coronary anatomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management strategies for patients with chronic coronary syndrome.
How similar studies have performed: While the approach of using CFD and OCT is established, the specific combination of assessments in this study is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Warsaw, Masovian Voivodeship
- Medical University of Warsaw — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Mariusz Tomaniak
- Email: mariusz.tomaniak@wum.edu.pl
- Phone: +48 22 5991951
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.