Status:
COMPLETED
PreDiction and Validation of Clinical CoursE of Coronary Artery DiSease With CT-Derived Non-Invasive HemodYnamic Phenotyping and Plaque Characterization (DESTINY Study)
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Elucid Bioimaging Inc.
Shanghai Institute of Cardiovascular Diseases
Conditions:
Acute Coronary Syndrome
Ischemic Heart Disease
Eligibility:
All Genders
Brief 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. The main ...
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 objectiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT04794868
Start Date
April 1 2020
End Date
December 31 2024
Last Update
March 14 2025
Active Locations (2)
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1
Shanghai Institute of Cardiovascular Diseases
Shanghai, China
2
Samsung Medical Center
Seoul, South Korea, 06351