Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamics II (EMERALD II) Study

Acute Myocardial Infarction Clinical Trial

— EMERALD II  

Official title:

Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamics II (EMERALD II) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03591328
• Other study ID #: NCT1869
• Status: Active, not recruiting
• Start date: July 9, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 429
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients who presented with ACS* and underwent invasive coronary angiography with identifiable culprit lesion

2. 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.

3. Time limit of CCTA: 1 months ~ 3 years prior to the event.

• Definition of ACS:

A. The patients with acute myocardial infarction should have cardiac enzyme elevation and identified culprit lesion confirmed by invasive coronary angiography, IVUS, or OCT. B. 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. Exclusion criteria for Patient enrollment

1. Patients with ACS without clear evidence of culprit lesion

2. Patients with stents in two or more vessel territories prior to CCTA

3. Poor quality of CCTA which is unsuitable for plaque and CFD analysis

4. Patients with ACS culprit lesion in a stented segment

5. Patients with previous history of coronary artery bypass graft surgery

6. Patients with revascularization after CCTA and before ACS event (*Patients with elective PCI for 1 vessel within 3 month after CCTA can be enrolled.

7. Secondary ACS due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.

8. Patients with unstable angina without evidence of plaque rupture Additional exclusion criteria for Computational Fluid Dynamics

9. Poor quality CCTA images unsuitable for CFD and plaque analysis

10. No unprocessed CCTA data

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Rupture
• Unstable Angina

Intervention

Diagnostic Test:
• Coronary CT angiography
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (40)

Lead Sponsor

Collaborator

Seoul National University Hospital

Aarhus University Hospital, Aichi Medical University, Chosun University Hospital, Chungnam National University Hospital, Ehime University Graduate School of Medicine, Emory University, Gifu Heart Center, Imperial College London, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center, Kobe University Hospital, Leiden University, Loyola University, Monash Heart, Monzino Cardiology Center, MOUNT SINAI HOSPITAL, National Cerebral and Cardiovascular Center, Odense University Hospital, OLV Hospital, Oxford University Hospital, Saiseikai Kumamoto Hospital, Semmelweis University, Seoul National University Bundang Hospital, Seoul National University Hospital Healthcare System Gangnam Center, Shin Koga Hospital, St. Luke's International Hospital, St. Mary's hostpital, Tokai University, Tokyo Medical Dental University, Tokyo Medical University Hachioji Medical Center, Toyohashi Heart Center, Tsuchiura Kyodo Hospital, Ulsan Hospital, Ulsan University Hospital, University of British Columbia, University of Milan, Wakayama Medical University, Weil Cornell Medical College, West Penn Allegheny Health System

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	discrimination index of prediction model	discrimination index of prediction model	1 months - 3 years