MedTrace Logo

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

NCT04794868 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 356

Last updated 2025-03-14

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

CCTA-derived high risk plaque characteristics

Presence of CCTA-derived high risk plaque characteristics

DIAGNOSTIC_TEST

CFD-derived hemodynamic parameters

CFD-derived hemodynamic parameters

Sponsors & Collaborators

  • Elucid Bioimaging Inc.

    collaborator INDUSTRY

  • Shanghai Institute of Cardiovascular Diseases

    collaborator OTHER

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Joo Myung Lee, MD, MPH, PhD · Samsung Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China
  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794868 on ClinicalTrials.gov