Acute Myocardial InfarctionEMERALD IINCT03591328
Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamics II (EMERALD II) Study
An observational study of Acute Myocardial Infarction and Unstable Angina, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The EMERALD II study is a multinational, multicenter, and retrospective study. ACS patients who underwent CCTA from 1 months to 3 years prior to the event will be retrospectively identified. Plaques in the non-culprit vessels will be regarded as a primary control group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction, Unstable Angina
- What is being tested?
- Coronary CT angiography
- How many people
- 429 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jul 2018to 31 Dec 2022
- How long will I take part?
- 3 Years
- 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 presented with acute coronary syndrome (acute myocardial infarction or unstable angina) and had undergone CCTA from 1 months to 3 years prior to the event.
Who may be able to join
- Patients who presented with ACS* and underwent invasive coronary angiography with identifiable culprit lesion
- The patients who underwent coronary CT angiography, regardless of the reason (for example, routine healthcare check-up, or evaluation for stable angina or atypical chest pain) prior to the acute event.
- Time limit of CCTA: 1 months ~ 3 years prior to the event.
- Definition of ACS:
- The patients with acute myocardial infarction should have cardiac enzyme elevation and identified culprit lesion confirmed by invasive coronary angiography, IVUS, or OCT.
- The patients with unstable angina should have evidence of plaque rupture, which includes at least one of the following: (1) the presence of plaque rupture or haziness including thrombus at invasive coronary angiography, (2) angiographic stenosis ≥90%, or (3) the evidence of rupture confirmed by IVUS or OCT.
Who cannot join
- Patients with ACS without clear evidence of culprit lesion
- Patients with stents in two or more vessel territories prior to CCTA
- Poor quality of CCTA which is unsuitable for plaque and CFD analysis
- Patients with ACS culprit lesion in a stented segment
- Patients with previous history of coronary artery bypass graft surgery
- Patients with revascularization after CCTA and before ACS event (*Patients with elective PCI for 1 vessel within 3 month after CCTA can be enrolled.
Show all 10Show fewer
- Secondary ACS due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.
- Patients with unstable angina without evidence of plaque rupture Additional exclusion criteria for Computational Fluid Dynamics
- Poor quality CCTA images unsuitable for CFD and plaque analysis
- No unprocessed CCTA data
Trial locations and contacts
1 site in 1 country.
About this study
The EMERALD II study is a multinational, multicenter, and retrospective study. ACS patients who underwent CCTA from 1 months to 3 years prior to the event will be retrospectively identified. Plaques in the non-culprit vessels will be regarded as a primary control group.
Read the detailed description
The mechanisms of plaque rupture are not fully understood. Hemodynamic forces, plaque vulnerability, and the interaction between these factors may cause plaque instability and subsequent acute coronary syndrome (ACS). Previously, the first-in-human study, EMERALD I, showed that the addition of hemodynamic parameters calculated noninvasively from coronary computed tomography (CCTA) using computational fluid dynamics (CFD) improved the ability to predict the risk of ACS compared with conventional approaches based on anatomical stenosis severity and adverse plaque characteristics. In addition to hemodynamic properties, quantified compositional plaque volumes such as fibrofatty and necrotic core volume (FFNC) or low-attenuation plaque burden (% plaque to vessel volume) have been proven to be robust prognostic indicators of ACS. While various hemodynamic and plaque features predictive of ACS have been introduced, the relative importance among them and the additive value of the risk model with the best features over the current diagnostic scheme of CCTA have not been proposed. In this regard, we designed the subsequent EMERALD II study to find the best hemodynamic and plaque features in prediction of ACS from comprehensive CCTA analysis, including per-lesion and per-vessel plaque quantification and hemodynamic analysis, and to investigate whether a comprehensive risk prediction model with them has an incremental value in a larger population.
- Conditions
- Acute Myocardial Infarction, Unstable Angina
- Being tested
- Coronary CT angiography
- Keywords
- Acute myocardial infarction, Unstable angina, Acute coronary syndrome, Computational fluid dynamics, Coronary computed tomography angiography, Fractional flow reserve
- Medical subject headings
- Angina, Unstable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT angiographyDiagnostic test
Comprehensive CCTA analysis of all culprit and non-culprit lesions to obtain their per-lesion and per-vessel quantitative, qualitative plaque, and hemodynamic features is performed by the independent core laboratory (HeartFlow, Mountain View, CA, USA) blinded to patient characteristics and ICA findings.
The current CCTA reporting variables, including % diameter stenosis, segment involvement score (SIS), and HRP features, are obtained for all lesions by another independent core laboratory (University of British Columbia, Vancouver, Canada) to construct a reference model. ICA and invasive imaging studies performed at the event of ACS are analyzed by the independent core laboratory (Samsung Medical Center, Seoul, Korea) to define the culprit lesion blinded to CCTA findings. Other independent experts match culprit and non-culprit lesion data between ICA and CCTA findings.
| Study group | Role | What they receive |
|---|---|---|
| Culprit | Plaques which is related with acute coronary syndrome Receives: Diagnostic Test: Coronary CT angiography | |
| Non-culprit | Plaques which is not related with acute coronary syndrome Receives: Diagnostic Test: Coronary CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
discrimination index of prediction model
discrimination index of prediction model
Measured: 1 months - 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start9 Jul 2018
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Other
- Enrolment
- 429 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University Ilsan Paik Hospital, St. Mary's hostpital, Odense University Hospital, University of Milan, Imperial College London, Aarhus University Hospital, Semmelweis University, Oxford University Hospitals NHS Trust, Emory University, Ehime University Graduate School of Medicine, Gifu Heart Center, Wakayama Medical University, Keimyung University Dongsan Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital Healthcare System Gangnam Center, Chosun University Hospital, Chungnam National University Hospital, Monzino Cardiology Center, OLV Hospital, Monash Heart, University of British Columbia, MOUNT SINAI HOSPITAL, Tokyo Medical University Hachioji Medical Center, Tokai University, St. Luke's International Hospital, Aichi Medical University, Toyohashi Heart Center, Kobe University Hospital, National Cerebral and Cardiovascular Center, Japan, Shin Koga Hospital, Saiseikai Kumamoto Hospital, Tsuchiura Kyodo Hospital, Tokyo Medical Dental University, Loyola University, Leiden University, Weill Medical College of Cornell University, West Penn Allegheny Health System, Ulsan Hospital, Ulsan University Hospital
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD,PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591328
- Sponsor's protocol ID
- NCT1869
- Acronym
- EMERALD II
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2018
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koskinas KC, Ughi GJ, Windecker S, Tearney GJ, Raber L. Intracoronary imaging of coronary atherosclerosis: validation for diagnosis, prognosis and treatment. Eur Heart J. 2016 Feb 7;37(6):524-35a-c. doi: 10.1093/eurheartj/ehv642. Epub 2015 Dec 11.
PubMed 26655874Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
PubMed 21247313Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Ozaki Y, Marco V, Boi A, Fineschi M, Fabbiocchi F, Taglieri N, Niccoli G, Trani C, Versaci F, Calligaris G, Ruscica G, Di Giorgio A, Vergallo R, Albertucci M, Biondi-Zoccai G, Tamburino C, Crea F, Alfonso F, Arbustini E. Relationship between coronary plaque morphology of the left anterior descending artery and 12 months clinical outcome: the CLIMA study. Eur Heart J. 2020 Jan 14;41(3):383-391. doi: 10.1093/eurheartj/ehz520.
PubMed 31504405Maurovich-Horvat P, Ferencik M, Voros S, Merkely B, Hoffmann U. Comprehensive plaque assessment by coronary CT angiography. Nat Rev Cardiol. 2014 Jul;11(7):390-402. doi: 10.1038/nrcardio.2014.60. Epub 2014 Apr 22.
PubMed 24755916Motoyama S, Ito H, Sarai M, Kondo T, Kawai H, Nagahara Y, Harigaya H, Kan S, Anno H, Takahashi H, Naruse H, Ishii J, Hecht H, Shaw LJ, Ozaki Y, Narula J. Plaque Characterization by Coronary Computed Tomography Angiography and the Likelihood of Acute Coronary Events in Mid-Term Follow-Up. J Am Coll Cardiol. 2015 Jul 28;66(4):337-46. doi: 10.1016/j.jacc.2015.05.069.
PubMed 26205589Yang S, Koo BK, Narula J. Interactions Between Morphological Plaque Characteristics and Coronary Physiology: From Pathophysiological Basis to Clinical Implications. JACC Cardiovasc Imaging. 2022 Jun;15(6):1139-1151. doi: 10.1016/j.jcmg.2021.10.009. Epub 2021 Dec 15.
PubMed 34922863Taylor CA, Fonte TA, Min JK. Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of fractional flow reserve: scientific basis. J Am Coll Cardiol. 2013 Jun 4;61(22):2233-41. doi: 10.1016/j.jacc.2012.11.083. Epub 2013 Apr 3.
PubMed 23562923Choi G, Lee JM, Kim HJ, Park JB, Sankaran S, Otake H, Doh JH, Nam CW, Shin ES, Taylor CA, Koo BK. Coronary Artery Axial Plaque Stress and its Relationship With Lesion Geometry: Application of Computational Fluid Dynamics to Coronary CT Angiography. JACC Cardiovasc Imaging. 2015 Oct;8(10):1156-1166. doi: 10.1016/j.jcmg.2015.04.024. Epub 2015 Sep 9.
PubMed 26363834Park JB, Choi G, Chun EJ, Kim HJ, Park J, Jung JH, Lee MH, Otake H, Doh JH, Nam CW, Shin ES, De Bruyne B, Taylor CA, Koo BK. Computational fluid dynamic measures of wall shear stress are related to coronary lesion characteristics. Heart. 2016 Oct 15;102(20):1655-61. doi: 10.1136/heartjnl-2016-309299. Epub 2016 Jun 14.
PubMed 27302987Lee 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 29550316Samady H, Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Maynard C, Timmins LH, Quyyumi AA, Giddens DP. Coronary artery wall shear stress is associated with progression and transformation of atherosclerotic plaque and arterial remodeling in patients with coronary artery disease. Circulation. 2011 Aug 16;124(7):779-88. doi: 10.1161/CIRCULATIONAHA.111.021824. Epub 2011 Jul 25.
PubMed 21788584Lee JM, Choi G, Hwang D, Park J, Kim HJ, Doh JH, Nam CW, Na SH, Shin ES, Taylor CA, Koo BK. Impact of Longitudinal Lesion Geometry on Location of Plaque Rupture and Clinical Presentations. JACC Cardiovasc Imaging. 2017 Jun;10(6):677-688. doi: 10.1016/j.jcmg.2016.04.012. Epub 2016 Sep 21.
PubMed 27665158Chang HJ, Lin FY, Lee SE, Andreini D, Bax J, Cademartiri F, Chinnaiyan K, Chow BJW, Conte E, Cury RC, Feuchtner G, Hadamitzky M, Kim YJ, Leipsic J, Maffei E, Marques H, Plank F, Pontone G, Raff GL, van Rosendael AR, Villines TC, Weirich HG, Al'Aref SJ, Baskaran L, Cho I, Danad I, Han D, Heo R, Lee JH, Rivzi A, Stuijfzand WJ, Gransar H, Lu Y, Sung JM, Park HB, Berman DS, Budoff MJ, Samady H, Shaw LJ, Stone PH, Virmani R, Narula J, Min JK. Coronary Atherosclerotic Precursors of Acute Coronary Syndromes. J Am Coll Cardiol. 2018 Jun 5;71(22):2511-2522. doi: 10.1016/j.jacc.2018.02.079.
PubMed 29852975Williams MC, Kwiecinski J, Doris M, McElhinney P, D'Souza MS, Cadet S, Adamson PD, Moss AJ, Alam S, Hunter A, Shah ASV, Mills NL, Pawade T, Wang C, Weir McCall J, Bonnici-Mallia M, Murrills C, Roditi G, van Beek EJR, Shaw LJ, Nicol ED, Berman DS, Slomka PJ, Newby DE, Dweck MR, Dey D. Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART). Circulation. 2020 May 5;141(18):1452-1462. doi: 10.1161/CIRCULATIONAHA.119.044720. Epub 2020 Mar 16.
PubMed 32174130Yang S, Koo BK, Hoshino M, Lee JM, Murai T, Park J, Zhang J, Hwang D, Shin ES, Doh JH, Nam CW, Wang J, Chen S, Tanaka N, Matsuo H, Akasaka T, Choi G, Petersen K, Chang HJ, Kakuta T, Narula J. CT Angiographic and Plaque Predictors of Functionally Significant Coronary Disease and Outcome Using Machine Learning. JACC Cardiovasc Imaging. 2021 Mar;14(3):629-641. doi: 10.1016/j.jcmg.2020.08.025. Epub 2020 Nov 25.
PubMed 33248965
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. 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 II (EMERALD II) Study
- ClinicalTrials.gov ID
- NCT03591328
- Acronym / sponsor ID
- EMERALD II / NCT1869
- Conditions
- Acute Myocardial Infarction, Unstable Angina
- Keywords
- Acute myocardial infarction, Unstable angina, Acute coronary syndrome, Computational fluid dynamics, Coronary computed tomography angiography, Fractional flow reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 429 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Inje University Ilsan Paik Hospital, St. Mary's hostpital, Odense University Hospital, University of Milan, Imperial College London, Aarhus University Hospital, Semmelweis University, Oxford University Hospitals NHS Trust, Emory University, Ehime University Graduate School of Medicine, Gifu Heart Center, Wakayama Medical University, Keimyung University Dongsan Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital Healthcare System Gangnam Center, Chosun University Hospital, Chungnam National University Hospital, Monzino Cardiology Center, OLV Hospital, Monash Heart, University of British Columbia, MOUNT SINAI HOSPITAL, Tokyo Medical University Hachioji Medical Center, Tokai University, St. Luke's International Hospital, Aichi Medical University, Toyohashi Heart Center, Kobe University Hospital, National Cerebral and Cardiovascular Center, Japan, Shin Koga Hospital, Saiseikai Kumamoto Hospital, Tsuchiura Kyodo Hospital, Tokyo Medical Dental University, Loyola University, Leiden University, Weill Medical College of Cornell University, West Penn Allegheny Health System, Ulsan Hospital, Ulsan University Hospital
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Jul 2018 (actual)
- 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 II study is a multinational, multicenter, and retrospective study. ACS patients who underwent CCTA from 1 months to 3 years prior to the event will be retrospectively identified. Plaques in the non-culprit vessels will be regarded as a primary control group.
Detailed description
The mechanisms of plaque rupture are not fully understood. Hemodynamic forces, plaque vulnerability, and the interaction between these factors may cause plaque instability and subsequent acute coronary syndrome (ACS). Previously, the first-in-human study, EMERALD I, showed that the addition of hemodynamic parameters calculated noninvasively from coronary computed tomography (CCTA) using computational fluid dynamics (CFD) improved the ability to predict the risk of ACS compared with conventional approaches based on anatomical stenosis severity and adverse plaque characteristics. In addition to hemodynamic properties, quantified compositional plaque volumes such as fibrofatty and necrotic core volume (FFNC) or low-attenuation plaque burden (% plaque to vessel volume) have been proven to be robust prognostic indicators of ACS. While various hemodynamic and plaque features predictive of ACS have been introduced, the relative importance among them and the additive value of the risk model with the best features over the current diagnostic scheme of CCTA have not been proposed. In this regard, we designed the subsequent EMERALD II study to find the best hemodynamic and plaque features in prediction of ACS from comprehensive CCTA analysis, including per-lesion and per-vessel plaque quantification and hemodynamic analysis, and to investigate whether a comprehensive risk prediction model with them has an incremental value in a larger population.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culprit | – | Diagnostic Test: Coronary CT angiographyPlaques which is related with acute coronary syndrome |
| Non-culprit | – | Diagnostic Test: Coronary CT angiographyPlaques which is not related with acute coronary syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who presented with acute coronary syndrome (acute myocardial infarction or unstable angina) and had undergone CCTA from 1 months to 3 years prior to the event.
Key inclusion criteria (6 listed)
- Patients who presented with ACS* and underwent invasive coronary angiography with identifiable culprit lesion
- The patients who underwent coronary CT angiography, regardless of the reason (for example, routine healthcare check-up, or evaluation for stable angina or atypical chest pain) prior to the acute event.
- Time limit of CCTA: 1 months ~ 3 years prior to the event.
- The patients with acute myocardial infarction should have cardiac enzyme elevation and identified culprit lesion confirmed by invasive coronary angiography, IVUS, or OCT.
- The patients with unstable angina should have evidence of plaque rupture, which includes at least one of the following: (1) the presence of plaque rupture or haziness including thrombus at invasive coronary angiography, (2) angiographic stenosis ≥90%, or (3) the evidence of rupture confirmed by IVUS or OCT.
Key exclusion criteria (10 listed)
- Patients with ACS without clear evidence of culprit lesion
- Patients with stents in two or more vessel territories prior to CCTA
- Poor quality of CCTA which is unsuitable for plaque and CFD analysis
- Patients with ACS culprit lesion in a stented segment
- Patients with previous history of coronary artery bypass graft surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary CT angiographyComprehensive CCTA analysis of all culprit and non-culprit lesions to obtain their per-lesion and per-vessel quantitative, qualitative plaque, and hemodynamic features is performed by the independent core laboratory (HeartFlow, Mountain View, CA, USA) blinded to patient characteristics and ICA findings. The current CCTA reporting variables, including % diameter stenosis, segment involvement score (SIS), and HRP features, are obtained for all lesions by another independent core laboratory (University of British Columbia, Vancouver, Canada) to construct a reference model. ICA and invasive imaging studies performed at the event of ACS are analyzed by the independent core laboratory (Samsung Medical Center, Seoul, Korea) to define the culprit lesion blinded to CCTA findings. Other independent experts match culprit and non-culprit lesion data between ICA and CCTA findings. | Diagnostic test | Culprit, Non-culprit |
Primary outcome
discrimination index of prediction model
Time frame: 1 months - 3 years
discrimination index of prediction model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 26655874Koskinas KC, Ughi GJ, Windecker S, Tearney GJ, Raber L. Intracoronary imaging of coronary atherosclerosis: validation for diagnosis, prognosis and treatment. Eur Heart J. 2016 Feb 7;37(6):524-35a-c. doi: 10.1093/eurheartj/ehv642. Epub 2015 Dec 11.
- Background: PubMed 21247313Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.
- Background: PubMed 31504405Prati F, Romagnoli E, Gatto L, La Manna A, Burzotta F, Ozaki Y, Marco V, Boi A, Fineschi M, Fabbiocchi F, Taglieri N, Niccoli G, Trani C, Versaci F, Calligaris G, Ruscica G, Di Giorgio A, Vergallo R, Albertucci M, Biondi-Zoccai G, Tamburino C, Crea F, Alfonso F, Arbustini E. Relationship between coronary plaque morphology of the left anterior descending artery and 12 months clinical outcome: the CLIMA study. Eur Heart J. 2020 Jan 14;41(3):383-391. doi: 10.1093/eurheartj/ehz520.
- Background: PubMed 24755916Maurovich-Horvat P, Ferencik M, Voros S, Merkely B, Hoffmann U. Comprehensive plaque assessment by coronary CT angiography. Nat Rev Cardiol. 2014 Jul;11(7):390-402. doi: 10.1038/nrcardio.2014.60. Epub 2014 Apr 22.
- Background: PubMed 26205589Motoyama S, Ito H, Sarai M, Kondo T, Kawai H, Nagahara Y, Harigaya H, Kan S, Anno H, Takahashi H, Naruse H, Ishii J, Hecht H, Shaw LJ, Ozaki Y, Narula J. Plaque Characterization by Coronary Computed Tomography Angiography and the Likelihood of Acute Coronary Events in Mid-Term Follow-Up. J Am Coll Cardiol. 2015 Jul 28;66(4):337-46. doi: 10.1016/j.jacc.2015.05.069.
- Background: PubMed 34922863Yang S, Koo BK, Narula J. Interactions Between Morphological Plaque Characteristics and Coronary Physiology: From Pathophysiological Basis to Clinical Implications. JACC Cardiovasc Imaging. 2022 Jun;15(6):1139-1151. doi: 10.1016/j.jcmg.2021.10.009. Epub 2021 Dec 15.
- Background: PubMed 23562923Taylor CA, Fonte TA, Min JK. Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of fractional flow reserve: scientific basis. J Am Coll Cardiol. 2013 Jun 4;61(22):2233-41. doi: 10.1016/j.jacc.2012.11.083. Epub 2013 Apr 3.
- Background: PubMed 26363834Choi G, Lee JM, Kim HJ, Park JB, Sankaran S, Otake H, Doh JH, Nam CW, Shin ES, Taylor CA, Koo BK. Coronary Artery Axial Plaque Stress and its Relationship With Lesion Geometry: Application of Computational Fluid Dynamics to Coronary CT Angiography. JACC Cardiovasc Imaging. 2015 Oct;8(10):1156-1166. doi: 10.1016/j.jcmg.2015.04.024. Epub 2015 Sep 9.
- Background: PubMed 27302987Park JB, Choi G, Chun EJ, Kim HJ, Park J, Jung JH, Lee MH, Otake H, Doh JH, Nam CW, Shin ES, De Bruyne B, Taylor CA, Koo BK. Computational fluid dynamic measures of wall shear stress are related to coronary lesion characteristics. Heart. 2016 Oct 15;102(20):1655-61. doi: 10.1136/heartjnl-2016-309299. Epub 2016 Jun 14.
- Background: 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.
- Background: PubMed 21788584Samady H, Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Maynard C, Timmins LH, Quyyumi AA, Giddens DP. Coronary artery wall shear stress is associated with progression and transformation of atherosclerotic plaque and arterial remodeling in patients with coronary artery disease. Circulation. 2011 Aug 16;124(7):779-88. doi: 10.1161/CIRCULATIONAHA.111.021824. Epub 2011 Jul 25.
- Background: PubMed 27665158Lee JM, Choi G, Hwang D, Park J, Kim HJ, Doh JH, Nam CW, Na SH, Shin ES, Taylor CA, Koo BK. Impact of Longitudinal Lesion Geometry on Location of Plaque Rupture and Clinical Presentations. JACC Cardiovasc Imaging. 2017 Jun;10(6):677-688. doi: 10.1016/j.jcmg.2016.04.012. Epub 2016 Sep 21.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Unstable Angina, run by Seoul National University Hospital at 1 site 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 6 inclusion and 10 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
discrimination index of prediction model (time frame: 1 months - 3 years). 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 NCT03591328, which also lists 22 linked publications.
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 23 Aug 2022.