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

NCT03591328 | Unknown DMC

• 1 other identifier: NCT1869
• Study Type: observational
• Target: 429
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• discrimination index of prediction model

  discrimination index of prediction model

  1 months - 3 years

Study Arms (2)

Culprit

Plaques which is related with acute coronary syndrome

Diagnostic Test: Coronary CT angiography

Non-culprit

Plaques which is not related with acute coronary syndrome

Diagnostic Test: Coronary CT angiography

Interventions

Coronary CT angiography DIAGNOSTIC_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.

Culprit; Non-culprit

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 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.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• Secondary ACS due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.
• Poor quality CCTA images unsuitable for CFD and plaque analysis
• No unprocessed CCTA data

Sponsors & Collaborators

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

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (21)

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MeSH Terms

Conditions

Angina, Unstable; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bon-Kwon Koo, MD,PhD

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: July 19, 2018
• Study Start: July 9, 2018
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

KR (1)