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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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 Summary:

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 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:

    • 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 ]


    Current Secondary Outcome:

    • 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:

    • 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 ]


    Information By: Seoul National University Hospital

    Dates:
    Date Received: September 22, 2014
    Date Started: September 2014
    Date Completion: December 2017
    Last Updated: April 2, 2017
    Last Verified: April 2017