Clinical trial NCT02374775: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Plaque, Atherosclerotic
Rupture, Spontaneous
Keywords: 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
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: HeartFlow, Inc.
name: Kyoto University, Graduate School of Medicine
name: Inje University
name: Keimyung University Dongsan Medical Center
name: Ulsan University Hospital
name: Wakayama Medical University
name: Aarhus University Hospital
First posted: 2015-03-02
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces
timeFrame: from 1 month - 2 year
measure: The difference of net reclassification index between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces
timeFrame: from 1 month - 2 year
Secondary outcomes:
measure: The best cut-off value of axial plaque stress to induce plaque rupture.
timeFrame: from 1 month - 2 year
measure: The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture.
timeFrame: from 1 month - 2 year
measure: The independent predictors for the plaque rupture using generalized estimating equation, and the c-index of the predicting models.
timeFrame: from 1 month - 2 year
measure: The validity of rupture risk score which constructed from the predicting model.
timeFrame: from 1 month - 2 year
measure: 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.
timeFrame: from 1 month - 2 year
measure: The association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient).
timeFrame: from 1 month - 2 year
measure: The differences in axial plaque stress between Group A and Group B
timeFrame: from 1 month - 2 year
measure: The differences in plaque vulnerability (Housefiled unit of the plaque on CT) between Group A and Group B
timeFrame: from 1 month - 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.