Acute Coronary SyndromeDESTINYNCT04794868
PreDiction and Validation of Clinical CoursE of Coronary Artery DiSease With CT-Derived Non-Invasive HemodYnamic Phenotyping and Plaque Characterization (DESTINY Study)
An observational study of Acute Coronary Syndrome and Ischemic Heart Disease, run by Samsung Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Ischemic Heart Disease
- What is being tested?
- CCTA-derived high risk plaque characteristics and CFD-derived hemodynamic parameters
- How many people
- 356 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2020to 31 Dec 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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;
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization
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.
Read the detailed description
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.
- Conditions
- Acute Coronary Syndrome, Ischemic Heart Disease
- Being tested
- CCTA-derived high risk plaque characteristics, CFD-derived hemodynamic parameters
- Keywords
- acute coronary syndrome, plaque characteristics, fractional flow reserve, fractional myocardial mass
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA-derived high risk plaque characteristicsDiagnostic test
Presence of CCTA-derived high risk plaque characteristics
CFD-derived hemodynamic parametersDiagnostic test
CFD-derived hemodynamic parameters
| Study group | Role | What they receive |
|---|---|---|
| Culprit vessel of acute coronary syndrome | Culprit vessel of acute coronary syndrome Receives: 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 Receives: Diagnostic Test: CCTA-derived high risk plaque characteristics; Diagnostic Test: CFD-derived hemodynamic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute myocardial infarction
Target vessel-related acute myocardial infarction
Measured: 3 years after index CCTA
Revascularization
Target vessel-related revsacularization
Measured: 3 years after index CCTA
Secondary outcomes (4)
Target vessel failure
A composite of Cardiac death, Target vessel-related acute myocardial infarction, Target vessel-related revsacularization
Measured: 3 years after index CCTA
All-cause death
All-cause death
Measured: 3 years after index CCTA
Cardiac death
Death due to cardiac cause
Measured: 3 years after index CCTA
Major adverse cardiac and cerebral events
A composite of All-cause death, Target vessel-related acute myocardial infarction, Target vessel-related revsacularization, Cerebrovascular accident
Measured: 3 years after index CCTA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Apr 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 356 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Elucid Bioimaging Inc., Shanghai Institute of Cardiovascular Diseases
- Responsible party
- Principal investigator, Joo Myung Lee, Samsung Medical Center
- Investigators
- Joo Myung Lee, MD, MPH, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794868
- Sponsor's protocol ID
- NCT20210308-JM
- Acronym
- DESTINY
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2021
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anatomized patient data can be shared upon reasonable request after decision by principal investigator
Publications
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.
PubMed 39553907Lee 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.
PubMed 35677691