Acute Coronary Syndrome Clinical Trial
— DESTINYOfficial title:
Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization
Verified date | September 2022 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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 | Active, not recruiting |
Enrollment | 356 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Patients who presented with ACS and underwent invasive coronary angiography with identifiable culprit lesion 2. Patients who presented with stable ischemic heart disease and underwent invasive coronary angiography for the significant epicardial coronary stenosis 3. 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. 4. Time limit of CCTA: 6 months ~ 3 years prior to the event. 5. 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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Institute of Cardiovascular Diseases | Shanghai | |
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center | Elucid Bioimaging Inc., Shanghai Institute of Cardiovascular Diseases |
China, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute myocardial infarction | Target vessel-related acute myocardial infarction | 3 years after index CCTA | |
Primary | Revascularization | Target vessel-related revsacularization | 3 years after index CCTA | |
Secondary | Target vessel failure | A composite of Cardiac death, Target vessel-related acute myocardial infarction, Target vessel-related revsacularization | 3 years after index CCTA | |
Secondary | All-cause death | All-cause death | 3 years after index CCTA | |
Secondary | Cardiac death | Death due to cardiac cause | 3 years after index CCTA | |
Secondary | Major adverse cardiac and cerebral events | A composite of All-cause death, Target vessel-related acute myocardial infarction, Target vessel-related revsacularization, Cerebrovascular accident | 3 years after index CCTA |
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