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

NCT ID: NCT02374775

Last Updated: 2017-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Acute Coronary Syndrome Myocardial Infarction Plaque, Atherosclerotic Rupture, Spontaneous

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A (Culprit lesion)

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

No interventions assigned to this group

Group B (Non-culprit lesion)

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HeartFlow, Inc.

INDUSTRY

Sponsor Role collaborator

Kyoto University, Graduate School of Medicine

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role collaborator

Ulsan University Hospital

OTHER

Sponsor Role collaborator

Wakayama Medical University

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bon-Kwon Koo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bon-Kwon Koo, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Bon-Kwon Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Joo Myung Lee, MD, MPH

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee JM, Choi G, Koo BK, Hwang D, Park J, Zhang J, Kim KJ, Tong Y, Kim HJ, Grady L, Doh JH, Nam CW, Shin ES, Cho YS, Choi SY, Chun EJ, Choi JH, Norgaard BL, Christiansen EH, Niemen K, Otake H, Penicka M, de Bruyne B, Kubo T, Akasaka T, Narula J, Douglas PS, Taylor CA, Kim HS. Identification of High-Risk Plaques Destined to Cause Acute Coronary Syndrome Using Coronary Computed Tomographic Angiography and Computational Fluid Dynamics. JACC Cardiovasc Imaging. 2019 Jun;12(6):1032-1043. doi: 10.1016/j.jcmg.2018.01.023. Epub 2018 Mar 14.

Reference Type DERIVED
PMID: 29550316 (View on PubMed)

Other Identifiers

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NCT02374775

Identifier Type: -

Identifier Source: org_study_id

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