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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

Tracking Information
First Submitted Date September 22, 2014
First Posted Date March 2, 2015
Last Update Posted Date April 4, 2017
Study Start Date September 2014
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2016)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: February 23, 2015)
  • The differences in axial plaque stress between Group A and Group B [ Time Frame: from 1 month - 2 year ]
  • 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 ]
Change History Complete list of historical versions of study NCT02374775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 20, 2016)
  • The best cut-off value of axial plaque stress to induce plaque rupture. [ Time Frame: from 1 month - 2 year ]
  • The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture. [ Time Frame: from 1 month - 2 year ]
  • 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 ]
  • The validity of rupture risk score which constructed from the predicting model. [ Time Frame: from 1 month - 2 year ]
  • 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 ]
  • The association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient). [ Time Frame: from 1 month - 2 year ]
  • The differences in axial plaque stress between Group A and Group B [ Time Frame: from 1 month - 2 year ]
  • 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 ]
Original Secondary Outcome Measures
 (submitted: February 23, 2015)
  • The best cut-off value of axial plaque stress to induce plaque rupture. [ Time Frame: from 1 month - 2 year ]
  • The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture. [ Time Frame: from 1 month - 2 year ]
  • 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 ]
  • The validity of rupture risk score which constructed from the predicting model. [ Time Frame: from 1 month - 2 year ]
  • 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 ]
  • The association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient). [ Time Frame: from 1 month - 2 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamic
Official Title Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamics (EMERALD)
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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Plaque, Atherosclerotic
  • Rupture, Spontaneous
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * 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, Nørgaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: May 24, 2016)
77
Original Estimated Enrollment
 (submitted: February 23, 2015)
300
Estimated Study Completion Date December 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02374775
Other Study ID Numbers Not Provided
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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
Responsible Party Bon-Kwon Koo, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
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
Investigators
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
PRS Account Seoul National University Hospital
Verification Date April 2017