Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamic

• Conditions: Acute Coronary Syndrome; Myocardial Infarction; Rupture, Spontaneous; Plaque, Atherosclerotic

• Registration Number: NCT02374775
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The EMERALD trial is a multinational, multicenter study. The patients presented with AMI/definite evidence of plaque rupture and had underwent coronary CT angiography from 1 month to 2 year prior to the event will be retrospectively searched. Plaques in the non-culprit vessels will be regarded as internal control to the ruptured plaque in the culprit vessel.

Detailed Description

The mechanisms of plaque rupture have not been fully understood. Hemodynamic forces acting on the plaque, plaque vulnerability, and the interaction between two factors might be the most important mechanism to explain various feature and location of plaque rupture.

The objectives of the study are

1. To explore the interaction between hemodynamic forces measured by computational fluid dynamics (CFD) analysis and plaque vulnerability in culprit lesion of subsequent clinical events.

2. To build rupture risk scoring system, incorporating independent predictor for plaque rupture.

The EMERALD trial is a multinational and multicenter study. The patients presented with AMI/plaque rupture and had underwent coronary CT angiography from 1 month to 2 year prior to the event will be retrospectively searched. Plaques in the non-culprit vessels will be regarded as internal control to the ruptured plaque in the culprit vessel.

The enrollment criteria will be

1. Patients who presented with acute coronary syndrome with cardiac enzyme elevation (AMI)/plaque rupture.

2. Among those patients, the patients who underwent coronary CT angiography, regardless of the reason prior to the acute event will be searched. The time limit of coronary CT angiography will be 1 month \~ 2 year prior to the event.

The Computational Fluids Dynamics (CFD) and Fluid-Structural Interaction (FSI) simulation will be performed to comprehensively evaluate the total plaque forces and their interaction with the plaque.

The comparison groups will be defined as follows; The plaque in the culprit vessel of AMI will be defined the Group A. The plaque in the non-culprit vessel of AMI will be defined as internal control, Group B.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-03-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-02
• Last Update Posted: 2017-04-04
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Patients who experienced acute myocardial infarction from 2010-2014 whose diagnosis have confirmed by invasive coronary angiography with or without IVUS or OCT evaluation, and who underwent coronary CT angiography from 1 month to 2 year prior to the acute myocardial infarction event.

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Exclusion Criteria

• Acute coronary syndrome without cardiac enzyme elevation (unstable angina)
• Patients who did not underwent coronary CT angiography, 1 month to 2 years prior to the acute myocardial infarction
• Poor CT images (unable to reconstruct 3 dimensional coronary artery model)
• The time period between coronary CT angiography and acute myocardial infarction exceed more than 2 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces	from 1 month - 2 year	Model 1 : percent diameter stenosis + adverse plaque characteristics defined by CT angiography Model 2 : percent diameter stenosis + adverse plaque characteristics defined by CT angiography + Hemodynamic forces defined by computational fluid dynamics
The difference of net reclassification index between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces	from 1 month - 2 year	Model 1 : percent diameter stenosis + adverse plaque characteristics defined by CT angiography Model 2 : percent diameter stenosis + adverse plaque characteristics defined by CT angiography + Hemodynamic forces defined by computational fluid dynamics

Secondary Outcome Measures

Name	Time	Method
The independent predictors for the plaque rupture using generalized estimating equation, and the c-index of the predicting models.	from 1 month - 2 year
The association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient).	from 1 month - 2 year
The differences in plaque vulnerability (Housefiled unit of the plaque on CT) between Group A and Group B	from 1 month - 2 year
The differences in axial plaque stress between Group A and Group B	from 1 month - 2 year
The best cut-off value of axial plaque stress to induce plaque rupture.	from 1 month - 2 year
The validity of rupture risk score which constructed from the predicting model.	from 1 month - 2 year
The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture.	from 1 month - 2 year
The differences in other hemodynamic parameters for example, pressure gradient, delta pressure, FFRCT, average and peak wall shear stress between Group A and Group B.	from 1 month - 2 year

Trial Locations

Locations (2)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of