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NCT Number: NCT04794868

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Institute of Cardiovascular Diseases, Shanghai, China

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About this study

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.

CCTA images were screened for plaque characteristics and CFD analysis at core laboratories in Elucid Bioimaging, Inc, MA, USA and Shanghai Institute of Cardiovascular Diseases, Shanghai, China, respectively. Lesions with diameter stenosis (DS) > 30% based on CCTA evaluation were included analysis. The presence of conventional CCTA-HRPC (minimum lumen area<<4 mm2, plaque burden≥70%, low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) and parameters from tissue characterization using VascuCAP software will be assessed in each lesion by an independent observer blinded to the clinical data and CFD results. The hemodynamic parameters from CFD will include 1) per-vessel FFR derived from CCTA (FFRCT); 2) change in FFRCT across the lesion (△FFRCT); 3) FFRCT pullback pressure gradient (PPG) index (FFRCT-PPG index); 4) Fractional myocardial mass (FMM) of the target stenosis.

Using the occurrence of ACS or PCI for the progressed lesion as clinical endpoint, prognostic implications of CCTA-derived HRPC or hemodynamic parameters will be analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

for Patient enrollment

  • 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

Treatment and study plan

CCTA-derived high risk plaque characteristics

Diagnostic Test

Presence of CCTA-derived high risk plaque characteristics

CFD-derived hemodynamic parameters

Diagnostic Test

CFD-derived hemodynamic parameters

Primary outcomes

  1. Acute myocardial infarction

    Time frame: 3 years after index CCTA

    Target vessel-related acute myocardial infarction

  2. Revascularization

    Time frame: 3 years after index CCTA

    Target vessel-related revsacularization

Secondary outcomes

  1. Target vessel failure

    Time frame: 3 years after index CCTA

    A composite of Cardiac death, Target vessel-related acute myocardial infarction, Target vessel-related revsacularization

  2. All-cause death

    Time frame: 3 years after index CCTA

    All-cause death

  3. Cardiac death

    Time frame: 3 years after index CCTA

    Death due to cardiac cause

  4. Major adverse cardiac and cerebral events

    Time frame: 3 years after index CCTA

    A composite of All-cause death, Target vessel-related acute myocardial infarction, Target vessel-related revsacularization, Cerebrovascular accident

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Elucid Bioimaging Inc.
  • Shanghai Institute of Cardiovascular Diseases

Registry information

Official study title

Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization

Acronym: DESTINY

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2021
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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