Clinical trial NCT06700018: Flow Patterns and Stent Thrombosis
Official title: Development of a Novel Method for Detailed Evaluation of Blood Flow Patterns in Stented Segments and Assessment of Their Role in Stent Thrombosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stent Thrombosis
Keywords: stent thrombosis
endothelial shear stress
optical coherence tomography
blood flow simulations
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Barts Helth NHS Trust
name: Oxford University Hospitals NHS Trust
name: Royal Free Hospital NHS Foundation Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: Mid and South Essex NHS Foundation Trust
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Liverpool Heart and Chest Hospital NHS Foundation Trust
name: Manchester University NHS Foundation Trust
name: King's College Hospital NHS Trust
name: San Giovanni Addolorata Hospital
name: Medstar Health Research Institute
name: Medical University of Warsaw
name: Insel Gruppe AG, University Hospital Bern
name: Hospital San Carlos, Madrid
name: The Leeds Teaching Hospitals NHS Trust
name: McMaster University Health Sciences Centre
name: Fujita Health University
name: Harbin Medical University
name: Yale University
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Erasmus Medical Center
name: Radbound University Medical Center
name: Department of Cardiovascular Surgery, German Heart Center Munich
name: Columbia University
name: The Queen Elizabeth Hospital
name: Yonsei University Hospital, Seoul, South Korea
name: Nara Medical University
name: Shinshu University School of Medicine
name: University Hospitals Sussex NHS Foundation Trust
name: Galeazzi Sant'Ambrogio Hospital - Milan
name: CORRIB Core Lab, University of Galway
First posted: 2024-11-21
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 120 patients who have undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent

Brief summary: The goal of this observational study is to study the effect of haemodynamic forces on thrombus formation and identify haemodynamic markers that predict stent thrombosis events in patients who have undergone OCT-guided percutaneous coronary interventions.

The primary objective of the study is to examine the efficacy of blood flow patterns in predicting stent thrombosis. Researchers will compare the blood flow patterns of the stent thrombosis group with that of the control group to understand the influence of blood flow patterns on thrombus formation and progression.

Detailed description: The incidences of Stent Thrombosis (ST) remain high in complex lesions and in high-risk patients. The use of intravascular imaging seems to be able to identify causes of ST, enabling prompt correction, and its use has been associated with better clinical outcomes in this setting. However, the efficacy of intravascular imaging features in predicting ST is limited. Computational fluid dynamic studies have shown that the local hemodynamic forces distribution has an effect on thrombus formation and can be responsible for the ST events. However, none of the studies today has explored in vivo the value of the flow disturbances in predicting events. The investigators have recently developed a method that is able to reconstruct vessel geometry accurately using coronary angiography and optical coherence tomography (OCT) data. Validation of this method in vitro and in human data showed promising results in accurately measuring shear stress and shear rate distribution.

This study, aims to explore the value of this method in predicting patients undergoing stent implantation with OCT imaging guidance that will suffer a ST. The investigators aim to collect data from 40 patients who had an ST after OCT-guided revascularization and from a control group of 80 patients who had no event after having stent implantation under OCT guidance. Investigators will further reconstruct the stented vessel from the OCT and the angiographic images, perform blood flow simulation and measure the shear rate and the shear stress in these two groups to explore the value of these metrics in predicting stent occlusion.

Eligibility criteria: Inclusion Criteria:

* Patients undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
* Patients who have suffered thrombosis post-stent implantation

Exclusion Criteria:

-

Primary outcomes:
measure: Haemodynamic shear stress and shear rate
timeFrame: 1.5 years
Secondary outcomes:
measure: OCT based stented segment reconstruction
timeFrame: 3 months
measure: Validation of the proposed reconstruction methodology
timeFrame: 4 months
measure: Development of automated frame work for reconstruction of stented segments
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University of London
Study officials:
References:
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