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

Myocardial Infarction Clinical Trial

— EMERALD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02374775
• Other study ID #: NCT02374775
• Status: Active, not recruiting
• Phase: N/A
• First received: September 22, 2014
• Last updated: April 2, 2017
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 77
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (8)

Lead Sponsor	Collaborator
Seoul National University Hospital	Aarhus University Hospital, HeartFlow, Inc., Inje University, Keimyung University Dongsan Medical Center, Kyoto University, Graduate School of Medicine, Ulsan University Hospital, Wakayama Medical University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces	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	from 1 month - 2 year
Primary	The difference of net reclassification index between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces	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	from 1 month - 2 year
Secondary	The best cut-off value of axial plaque stress to induce plaque rupture.		from 1 month - 2 year
Secondary	The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture.		from 1 month - 2 year
Secondary	The independent predictors for the plaque rupture using generalized estimating equation, and the c-index of the predicting models.		from 1 month - 2 year
Secondary	The validity of rupture risk score which constructed from the predicting model.		from 1 month - 2 year
Secondary	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
Secondary	The association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient).		from 1 month - 2 year
Secondary	The differences in axial plaque stress between Group A and Group B		from 1 month - 2 year
Secondary	The differences in plaque vulnerability (Housefiled unit of the plaque on CT) between Group A and Group B		from 1 month - 2 year