PreDiction and Validation of Clinical CoursE of Coronary Artery DiSease With CT-Derived Non-Invasive HemodYnamic Phenotyping and Plaque Characterization (DESTINY Study)

NCT04794868 | Completed DMC

• 1 other identifier: NCT20210308-JM
• Study Type: observational
• Target: 356
• Locations: 2 countries
• Sites: 2

Brief Summary

Acute coronary syndrome (ACS) and sudden cardiac death can be the first manifestation of coronary artery disease and are the leading cause of death in the majority of the world's population. The main pathophysiology of ACS is well-known and fibrous cap thickness, presence of a lipid core, and the degree of inflammation have been proposed as the key determinants of plaque vulnerability. Previous studies using virtual histology intravascular ultrasound or optical coherence tomography showed that clinical application of this concept improved risk prediction of ACS. However, these approaches have not been widely adopted in daily practice due to relatively low positive predictive values, low prevalence of high-risk plaques and the invasive nature of diagnostic modalities. Non-invasive imaging studies with coronary computed tomography angiography (CCTA) also showed the clinical value of CCTA-derived high risk plaque characteristics (HRPC). In addition, the recent progress in CCTA and computational fluid dynamics (CFD) technologies enables simultaneous assessment of anatomical lesion severity, presence of HRPC and quantification of hemodynamic forces acting on plaques in patient-specific geometric models. As plaque rupture is a complicated biomechanical process influenced by the structure and constituents of the plaque as well as the external mechanical and hemodynamic forces acting on the plaque, a comprehensive evaluation of lesion geometry, plaque characteristics and hemodynamic parameters may enhance the identification of high-risk plaque and the prediction of ACS risk. In this regard, the current study is designed to evaluate prognostic implications of comprehensive non-invasive hemodynamic assessment using CCTA and CFD in the identification of high risk plaques that caused subsequent ACS.

Conditions

Acute Coronary Syndrome; Ischemic Heart Disease

Keywords

acute coronary syndrome; plaque characteristics; fractional flow reserve; fractional myocardial mass

Outcome Measures

Primary Outcomes (2)

• Acute myocardial infarction

  Target vessel-related acute myocardial infarction

  3 years after index CCTA

• Revascularization

  Target vessel-related revsacularization

  3 years after index CCTA

Secondary Outcomes (4)

• Target vessel failure

  3 years after index CCTA

• All-cause death

  3 years after index CCTA

• Cardiac death

  3 years after index CCTA

• Major adverse cardiac and cerebral events

  3 years after index CCTA

Study Arms (2)

Culprit vessel of acute coronary syndrome

Culprit vessel of acute coronary syndrome

Diagnostic Test: CCTA-derived high risk plaque characteristics; Diagnostic Test: CFD-derived hemodynamic parameters

Non-culprit vessel of acute coronary syndrome

Non-culprit vessel of acute coronary syndrome

Diagnostic Test: CCTA-derived high risk plaque characteristics; Diagnostic Test: CFD-derived hemodynamic parameters

Interventions

CCTA-derived high risk plaque characteristics DIAGNOSTIC_TEST

Presence of CCTA-derived high risk plaque characteristics

Culprit vessel of acute coronary syndrome; Non-culprit vessel of acute coronary syndrome

CFD-derived hemodynamic parameters DIAGNOSTIC_TEST

CFD-derived hemodynamic parameters

Culprit vessel of acute coronary syndrome; Non-culprit vessel of acute coronary syndrome

Eligibility Criteria

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

Study Population

The study population was collected from Samsung Medical Center. Target population is patients who suffered a clearly documented ACS (acute myocardial infarction \[MI\] or unstable angina with objective evidence of plaque rupture) or those who underwent significant lesion progression in angiography and treated by percutaneous coronary intervention (PCI) and had undergone CCTA from 6 months to 3 years prior to the coronary events.

You may qualify if:

• Patients who presented with ACS and underwent invasive coronary angiography with identifiable culprit lesion
• Patients who presented with stable ischemic heart disease and underwent invasive coronary angiography for the significant epicardial coronary stenosis
• 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: 6 months \~ 3 years prior to the event.
• Definition of ACS:
• The patients with acute myocardial infarction should meet one of the following criteria;
• Cardiac enzyme elevation "and"
• Identified culprit lesion confirmed by invasive coronary angiography, IVUS, or OCT
• The patients with unstable angina should be accompanied by the evidence of plaque rupture confirmed with invasive coronary angiography, IVUS, or OCT

You may not qualify if:

• Patients with acute coronary syndrome 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 vessel
• Patients with previous history of coronary artery bypass graft surgery
• Secondary myocardial infarction due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.
• Poor quality CCTA images unsuitable for CFD analysis
• No available unprocessed CCTA data

Sponsors & Collaborators

• Samsung Medical Center: lead
• Elucid Bioimaging Inc.: collaborator
• Shanghai Institute of Cardiovascular Diseases: collaborator

Study Sites (2)

Shanghai Institute of Cardiovascular Diseases

Shanghai, China

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (2)

• Hong D, Dai N, Lee SH, Shin D, Choi KH, Kim SM, Kim HK, Jeon KH, Ha SJ, Lee KY, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Choe YH, Gwon HC, Ge J, Lee JM. Fractional Flow Reserve and Fractional Flow Reserve Gradient From CCTA for Predicting Future Coronary Events. JACC Asia. 2024 Aug 27;4(10):735-747. doi: 10.1016/j.jacasi.2024.06.007. eCollection 2024 Oct.

  PMID: 39553907 DERIVED

• Lee SH, Hong D, Dai N, Shin D, Choi KH, Kim SM, Kim HK, Jeon KH, Ha SJ, Lee KY, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Choe YH, Gwon HC, Ge J, Lee JM. Anatomic and Hemodynamic Plaque Characteristics for Subsequent Coronary Events. Front Cardiovasc Med. 2022 May 23;9:871450. doi: 10.3389/fcvm.2022.871450. eCollection 2022.

  PMID: 35677691 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: April 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

KR (1); CN (1)