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

Seoul National University

Status: Unknown

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02374775

NCT02374775

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

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

Trial design

77 participants in 2 patient groups

Group A (Culprit lesion)

Description:

The plaque in the culprit vessel of acute myocardial infarction will be defined the Group A.

Group B (Non-culprit lesion)

Description:

The plaque in the non-culprit vessel of acute myocardial infarction will be defined as internal control, Group B.