Ignite Creation Date:
2024-05-06 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03591328
Status:
UNKNOWN
Last Update Posted:
2022-08-23
First Post:
2018-07-08
Brief Title:
Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamics II EMERALD II Study
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamics II EMERALD II Study
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMERALD II
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None