Flow Patterns and Stent Thrombosis

Официальное название

Development of a Novel Method for Detailed Evaluation of Blood Flow Patterns in Stented Segments and Assessment of Their Role in Stent Thrombosis

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Haemodynamic shear stress and shear rate [Срок оценки: 1.5 years]

Вторичные конечные точки (3)

• OCT based stented segment reconstruction [Срок оценки: 3 months]
• Validation of the proposed reconstruction methodology [Срок оценки: 4 months]
• Development of automated frame work for reconstruction of stented segments [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• Queen Mary University of London — London

Публикации

• Gijsen F, Katagiri Y, Barlis P, Bourantas C, Collet C, Coskun U, Daemen J, Dijkstra J, Edelman E, Evans P, van der Heiden K, Hose R, Koo BK, Krams R, Marsden A, Migliavacca F, Onuma Y, Ooi A, Poon E, Samady H, Stone P, Takahashi K, Tang D, Thondapu V, Tenekecioglu E, Timmins L, Torii R, Wentzel J, Serruys P. Expert recommendations on the assessment of wall shear stress in human coronary arteries: PMID 31566246
• Li Y, Li Z, Holck EN, Xu B, Karanasos A, Fei Z, Chang Y, Chu M, Dijkstra J, Christiansen EH, Reiber JHC, Holm NR, Tu S. Local Flow Patterns After Implantation of Bioresorbable Vascular Scaffold in Coronary Bifurcations - Novel Findings by Computational Fluid Dynamics. Circ J. 2018 May 25;82(6):1575-1583. doi: 10.1253/circj.CJ-17-1332. Epub 2018 Mar 24. PMID 29576586
• O'Brien CC, Kolandaivelu K, Brown J, Lopes AC, Kunio M, Kolachalama VB, Edelman ER. Constraining OCT with Knowledge of Device Design Enables High Accuracy Hemodynamic Assessment of Endovascular Implants. PLoS One. 2016 Feb 23;11(2):e0149178. doi: 10.1371/journal.pone.0149178. eCollection 2016. PMID 26906566
• Migliori S, Chiastra C, Bologna M, Montin E, Dubini G, Aurigemma C, Fedele R, Burzotta F, Mainardi L, Migliavacca F. A framework for computational fluid dynamic analyses of patient-specific stented coronary arteries from optical coherence tomography images. Med Eng Phys. 2017 Sep;47:105-116. doi: 10.1016/j.medengphy.2017.06.027. Epub 2017 Jul 12. PMID 28711588
• Li Y, Gutierrez-Chico JL, Holm NR, Yang W, Hebsgaard L, Christiansen EH, Maeng M, Lassen JF, Yan F, Reiber JH, Tu S. Impact of Side Branch Modeling on Computation of Endothelial Shear Stress in Coronary Artery Disease: Coronary Tree Reconstruction by Fusion of 3D Angiography and OCT. J Am Coll Cardiol. 2015 Jul 14;66(2):125-35. doi: 10.1016/j.jacc.2015.05.008. PMID 26160628
• Torii R, Stettler R, Raber L, Zhang YJ, Karanasos A, Dijkstra J, Patel K, Crake T, Hamshere S, Garcia-Garcia HM, Tenekecioglu E, Ozkor M, Baumbach A, Windecker S, Serruys PW, Regar E, Mathur A, Bourantas CV. Implications of the local hemodynamic forces on the formation and destabilization of neoatherosclerotic lesions. Int J Cardiol. 2018 Dec 1;272:7-12. doi: 10.1016/j.ijcard.2018.06.065. Epub 201 PMID 30293579
• Tenekecioglu E, Torii R, Sotomi Y, Collet C, Dijkstra J, Miyazaki Y, Crake T, Su S, Costa R, Chamie D, Liew HB, Santoso T, Onuma Y, Abizaid A, Bourantas CV, Serruys PW. The Effect of Strut Protrusion on Shear Stress Distribution: Hemodynamic Insights From a Prospective Clinical Trial. JACC Cardiovasc Interv. 2017 Sep 11;10(17):1803-1805. doi: 10.1016/j.jcin.2017.06.020. No abstract available. PMID 28882287
• Torii R, Tenekecioglu E, Katagiri Y, Chichareon P, Sotomi Y, Dijkstra J, Asano T, Modolo R, Takahashi K, Jonker H, van Geuns R, Onuma Y, Pekkan K, Bourantas CV, Serruys PW. The impact of plaque type on strut embedment/protrusion and shear stress distribution in bioresorbable scaffold. Eur Heart J Cardiovasc Imaging. 2020 Apr 1;21(4):454-462. doi: 10.1093/ehjci/jez155. PMID 31215995

Идентификаторы

NCT: NCT06700018 · 331221

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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