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

NCT02374775 | Unknown DMC

• 1 other identifier: NCT02374775
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  from 1 month - 2 year

Secondary Outcomes (8)

• The best cut-off value of axial plaque stress to induce plaque rupture.

  from 1 month - 2 year

• The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture.

  from 1 month - 2 year

• The independent predictors for the plaque rupture using generalized estimating equation, and the c-index of the predicting models.

  from 1 month - 2 year

• The validity of rupture risk score which constructed from the predicting model.

  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.

  from 1 month - 2 year

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• HeartFlow, Inc.: collaborator
• Kyoto University, Graduate School of Medicine: collaborator
• Inje University: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Ulsan University Hospital: collaborator
• Wakayama Medical University: collaborator
• Aarhus University Hospital: collaborator

Study Sites (2)

Seoul national university hospital

Seoul, 110-744, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29550316 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Plaque, Atherosclerotic; Rupture, Spontaneous

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pathological Conditions, Anatomical

Study Officials

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Joo Myung Lee, MD, MPH

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: March 2, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (2)