High-risk Features of Coronary Lesions in CTA and OCT

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06089343
Collaborator
(none)
300
1
12
24.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Coronary CT angiography

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Exploring the High-risk Features of Coronary Lesions Using CT Angiography and Optical Coherence Tomography
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Culprit

Plaques which is related with acute coronary syndrome

Diagnostic Test: Coronary CT angiography
Comprehensive hemodynamic and plaque features derived from CTA and verified by OCT of all culprit and non-culprit lesions to predict ACS.

Non-culprit

Plaques which is not related with acute coronary syndrome

Diagnostic Test: Coronary CT angiography
Comprehensive hemodynamic and plaque features derived from CTA and verified by OCT of all culprit and non-culprit lesions to predict ACS.

Outcome Measures

Primary Outcome Measures

  1. discrimination index of prediction model [1 months - 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients who presented with ACS and underwent invasive coronary angiography or OCT

  2. The patients who underwent coronary CT angiography, regardless of the reason (for example, routine healthcare check-up, or evaluation for stable angina or atypical chest pain) prior to the acute event.

  3. Time limit of CCTA: 1 months ~ 3 years prior to the event.

  • Exclusion Criteria:

Patients with stents in two or more vessel territories prior to CCTA Poor quality of CCTA which is unsuitable for plaque and CFD analysis Patients with ACS culprit lesion in a stented segment Patients with previous history of coronary artery bypass graft surgery Patients with revascularization after CCTA and before ACS event Secondary ACS due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.

--Additional exclusion criteria for Computational Fluid Dynamics Poor quality CCTA images unsuitable for CFD and plaque analysis No unprocessed CCTA data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Hospital Fudan University Shanghai Shanghai China 200030

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT06089343
Other Study ID Numbers:
  • ACS-CTA&OCT
First Posted:
Oct 18, 2023
Last Update Posted:
Oct 18, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2023