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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Zhongshan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who presented with acute coronary syndrome (acute myocardial infarction or unstable angina) and had undergone CCTA from 1 months to 3 years prior to the event.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
discrimination index of prediction model	1 months - 3 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: ACS-CTA&OCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No