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

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ClinicalTrials.gov Identifier: NCT02374775
Recruitment Status : Unknown
Verified April 2017 by Bon-Kwon Koo, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2015
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
HeartFlow, Inc.
Kyoto University, Graduate School of Medicine
Inje University
Keimyung University Dongsan Medical Center
Ulsan University Hospital
Wakayama Medical University
Aarhus University Hospital
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital

Brief 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.

Condition or disease
Acute Coronary Syndrome Myocardial Infarction Plaque, Atherosclerotic Rupture, Spontaneous

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.


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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamics (EMERALD)
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort
Group A (Culprit lesion)
The plaque in the culprit vessel of acute myocardial infarction will be defined the Group A.
Group B (Non-culprit lesion)
The plaque in the non-culprit vessel of acute myocardial infarction will be defined as internal control, Group B.



Primary Outcome Measures :
  1. The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces [ Time Frame: from 1 month - 2 year ]
    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

  2. The difference of net reclassification index between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces [ Time Frame: from 1 month - 2 year ]
    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


Secondary Outcome Measures :
  1. The best cut-off value of axial plaque stress to induce plaque rupture. [ Time Frame: from 1 month - 2 year ]
  2. The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture. [ Time Frame: from 1 month - 2 year ]
  3. The independent predictors for the plaque rupture using generalized estimating equation, and the c-index of the predicting models. [ Time Frame: from 1 month - 2 year ]
  4. The validity of rupture risk score which constructed from the predicting model. [ Time Frame: from 1 month - 2 year ]
  5. 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. [ Time Frame: from 1 month - 2 year ]
  6. The association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient). [ Time Frame: from 1 month - 2 year ]
  7. The differences in axial plaque stress between Group A and Group B [ Time Frame: from 1 month - 2 year ]
  8. The differences in plaque vulnerability (Housefiled unit of the plaque on CT) between Group A and Group B [ Time Frame: from 1 month - 2 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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. Acute coronary syndrome without cardiac enzyme elevation (unstable angina) will be excluded. The time limit of the coronary CT angiography prior to the event is from 1 month to 2 year. Participating center will perform abovementioned search process.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374775


Locations
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Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Seoul National University Hospital
HeartFlow, Inc.
Kyoto University, Graduate School of Medicine
Inje University
Keimyung University Dongsan Medical Center
Ulsan University Hospital
Wakayama Medical University
Aarhus University Hospital
Investigators
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Study Chair: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
Study Director: Joo Myung Lee, MD, MPH Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bon-Kwon Koo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02374775     History of Changes
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After acceptance of first manuscript, the data will be shared upon request and permission of principal investigator and participants of the study

Keywords provided by Bon-Kwon Koo, Seoul National University Hospital:
axial plaque stress
pressure
pressure gradient
coronary plaque
plaque rupture
acute coronary syndrome
acute myocardial infarction
computational fluid dynamics
coronary computed tomography angiography
wall shear stress

Additional relevant MeSH terms:
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Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Rupture
Plaque, Atherosclerotic
Rupture, Spontaneous
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Wounds and Injuries
Pathological Conditions, Anatomical