NCT04794868Completed
PreDiction and Validation of Clinical CoursE of Coronary Artery DiSease With CT-Derived Non-Invasive HemodYnamic Phenotyping and Plaque Characterization (DESTINY Study)
Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization
Source: ClinicalTrials.gov · Last updated 14 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 356 (actual)
- First submitted
- 8 Mar 2021
- Start date
- 1 Apr 2020
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT04794868
What you commit to
- Study type: Observational
- Participants enrolled: 356
- From 1 Apr 2020 to the primary completion date, 31 Dec 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with stents in two or more vessel territories prior to CCTA
- Patients with previous history of coronary artery bypass graft surgery
Other illness
- Patients with acute coronary syndrome without clear evidence of culprit lesion
- Secondary myocardial infarction due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.
Other
- Poor quality of CCTA which is unsuitable for plaque and CFD analysis
- Patients with ACS culprit lesion in a stented vessel
- Poor quality CCTA images unsuitable for CFD analysis
- No available unprocessed CCTA data
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Institute of Cardiovascular Diseases Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
Related publications
- Prediction of coronary events by computed tomography-derived Murray law-based quantitative flow ratio.EuroIntervention · 2026 · PMID 42975599
This page is information, not medical advice. Discuss any trial with your doctor.