NCT02374775

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 77 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome
• Myocardial Infarction
• Plaque, Atherosclerotic
• Rupture, Spontaneous

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2015-03-02
• Last updated: 2017-04-04

Locations

2 sites across 1 country: South Korea