Clinical Trials Directory

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UnknownNCT06089343

High-risk Features of Coronary Lesions in CTA and OCT

Exploring the High-risk Features of Coronary Lesions Using CT Angiography and Optical Coherence Tomography

Status
Unknown
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Shanghai Zhongshan Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTCoronary CT angiographyComprehensive hemodynamic and plaque features derived from CTA and verified by OCT of all culprit and non-culprit lesions to predict ACS.

Timeline

Start date
2023-10-01
Primary completion
2024-10-01
Completion
2024-10-01
First posted
2023-10-18
Last updated
2023-10-18

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06089343. Inclusion in this directory is not an endorsement.