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
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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UNKNOWN
77 participants
OBSERVATIONAL
2014-09-30
2017-12-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_CONTROL
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
Exclusion Criteria
* 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
ALL
No
Sponsors
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HeartFlow, Inc.
INDUSTRY
Kyoto University, Graduate School of Medicine
OTHER
Inje University
OTHER
Keimyung University Dongsan Medical Center
OTHER
Ulsan University Hospital
OTHER
Wakayama Medical University
OTHER
Aarhus University Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Bon-Kwon Koo
Professor
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
Samsung Medical Center
Seoul, , South Korea
Countries
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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.
Other Identifiers
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NCT02374775
Identifier Type: -
Identifier Source: org_study_id
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