Viewing Study NCT06089343



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Last Modification Date: 2024-10-26 @ 3:11 PM
Study NCT ID: NCT06089343
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-10-18
First Post: 2023-10-13

Brief Title: High-risk Features of Coronary Lesions in CTA and OCT
Sponsor: Shanghai Zhongshan Hospital
Organization: Shanghai Zhongshan Hospital

Study Overview

Official Title: Exploring the High-risk Features of Coronary Lesions Using CT Angiography and Optical Coherence Tomography
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study is a multicenter and retrospective study ACS patients who underwent CCTA or OCT from 1 months to 3 years prior to the event will be retrospectively identified Plaques in the non-culprit vessels will be regarded as a primary control group
Detailed Description: The high-risk features of plaque rupture and subsequent acute coronary syndrome ACS are not fully identified Plaque features hemodynamic forces and the interaction between these factors may cause plaque instability and subsequent clinical events A previous study showed that the addition of hemodynamic parameters calculated noninvasively from coronary computed tomography CCTA using computational fluid dynamics such as wall shear stress and axial plaque stress improved the ability to predict the risk of ACS compared with conventional approaches based on anatomical stenosis severity and adverse plaque characteristics Wall shear stress and axial plaque stress derived from CT were highly correlated to those derived from optical coherence tomography OCT In addition other hemodynamic parameters such as oscillatory shear index endothelial shear stress ESS and spatial ESS gradient have also been demonstrated to be associated with unstable plaque In this regard we designed this study to find the best hemodynamic and plaque features derived from CTA and verified by OCT to predict ACS and to investigate whether a comprehensive risk prediction model with them has an incremental value in a larger population

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None