Acute Coronary SyndromeEMERALDNCT02374775
Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamic
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Seoul National University Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Plaque, Atherosclerotic
- How many people
- 77 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul national university hospital
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710
About this study
Official title: Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamics (EMERALD)
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.
Read the 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
- To explore the interaction between hemodynamic forces measured by computational fluid dynamics (CFD) analysis and plaque vulnerability in culprit lesion of subsequent clinical events.
- 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
- Patients who presented with acute coronary syndrome with cardiac enzyme elevation (AMI)/plaque rupture.
- 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
- 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
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Plaque, Atherosclerotic, Rupture, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces
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
Measured: from 1 month - 2 year
The difference of net reclassification index between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces
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
Measured: from 1 month - 2 year
Secondary outcomes (8)
The best cut-off value of axial plaque stress to induce plaque rupture.
Measured: from 1 month - 2 year
The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture.
Measured: from 1 month - 2 year
The independent predictors for the plaque rupture using generalized estimating equation, and the c-index of the predicting models.
Measured: from 1 month - 2 year
The validity of rupture risk score which constructed from the predicting model.
Measured: 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.
Measured: from 1 month - 2 year
The association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient).
Measured: from 1 month - 2 year
The differences in axial plaque stress between Group A and Group B
Measured: from 1 month - 2 year
The differences in plaque vulnerability (Housefiled unit of the plaque on CT) between Group A and Group B
Measured: from 1 month - 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Study chair, Seoul National University HospitalBon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University HospitalJoo Myung Lee, MD, MPH, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374775
- Sponsor's protocol ID
- NCT02374775
- Acronym
- EMERALD
- Status last verified
- Apr 2017
- First submitted
- 22 Sep 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After acceptance of first manuscript, the data will be shared upon request and permission of principal investigator and participants of the study
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, 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.
PubMed 29550316
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamics (EMERALD)
- ClinicalTrials.gov ID
- NCT02374775
- Acronym / sponsor ID
- EMERALD / NCT02374775
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- 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
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To explore the interaction between hemodynamic forces measured by computational fluid dynamics (CFD) analysis and plaque vulnerability in culprit lesion of subsequent clinical events.
- 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
- Patients who presented with acute coronary syndrome with cardiac enzyme elevation (AMI)/plaque rupture.
- 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 29550316Lee 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.
- Individual participant dataSharing planned: Yes. After acceptance of first manuscript, the data will be shared upon request and permission of principal investigator and participants of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon-Kwon Koo, MD, PhD study chair
Seoul National University Hospital
Bon-Kwon Koo, MD, PhD principal investigator
Seoul National University Hospital
Joo Myung Lee, MD, MPH study director
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.