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
- Are there results?
- None posted in the registry
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 (3)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
Gim DH, Lee SH, Ding D, Wang Z, Shin D, Kim SM, Lee SY, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Choe YH, Gwon HC, Tu S, Lee JM. Prediction of coronary events by computed tomography-derived Murray law-based quantitative flow ratio. EuroIntervention. 2026 Nov 2;22(21):e1146-e1156. doi: 10.4244/EIJ-D-26-00575.
PubMed 42975599Hong 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization
- ClinicalTrials.gov ID
- NCT04794868
- Acronym / sponsor ID
- DESTINY / NCT20210308-JM
- Conditions
- Acute Coronary Syndrome, Ischemic Heart Disease
- Keywords
- acute coronary syndrome, plaque characteristics, fractional flow reserve, fractional myocardial mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Elucid Bioimaging Inc., Shanghai Institute of Cardiovascular Diseases
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culprit vessel of acute coronary syndrome | – | Diagnostic Test: CCTA-derived high risk plaque characteristics, Diagnostic Test: CFD-derived hemodynamic parametersCulprit 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 parametersNon-culprit vessel of acute coronary syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTA-derived high risk plaque characteristicsPresence of CCTA-derived high risk plaque characteristics | Diagnostic test | Culprit vessel of acute coronary syndrome, Non-culprit vessel of acute coronary syndrome |
| CFD-derived hemodynamic parametersCFD-derived hemodynamic parameters | Diagnostic test | Culprit vessel of acute coronary syndrome, Non-culprit vessel of acute coronary syndrome |
Primary outcome
Acute myocardial infarction
Time frame: 3 years after index CCTA
Target vessel-related acute myocardial infarction
Revascularization
Time frame: 3 years after index CCTA
Target vessel-related revsacularization
4 secondary outcomes
Target vessel failure
Time frame: 3 years after index CCTA
All-cause death
Time frame: 3 years after index CCTA
Cardiac death
Time frame: 3 years after index CCTA
Major adverse cardiac and cerebral events
Time frame: 3 years after index CCTA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Derived from this study: PubMed 42975599Gim DH, Lee SH, Ding D, Wang Z, Shin D, Kim SM, Lee SY, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Choe YH, Gwon HC, Tu S, Lee JM. Prediction of coronary events by computed tomography-derived Murray law-based quantitative flow ratio. EuroIntervention. 2026 Nov 2;22(21):e1146-e1156. doi: 10.4244/EIJ-D-26-00575.
- Derived from this study: PubMed 39553907Hong 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.
- Derived from this study: PubMed 35677691Lee 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.
- Individual participant dataSharing planned: Undecided. Anatomized patient data can be shared upon reasonable request after decision by principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Myung Lee, MD, MPH, PhD principal investigator
Samsung Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Ischemic Heart Disease, run by Samsung Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute myocardial infarction (time frame: 3 years after index CCTA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794868, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.