Actively Recruiting
Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
Led by Samsung Medical Center · Updated on 2025-11-20
2000
Participants Needed
22
Research Sites
378 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial. The study will compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive coronary artery disease (CAD) on coronary computed tomography-angiography (CCTA).
CONDITIONS
Official Title
Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- New or worsening chest pain, equivalent symptoms, or abnormal lab tests suggesting ischemic changes evaluated by coronary CT-angiography
- Any other clinical reason for physician to proceed with coronary CT-angiography
- Obstructive coronary artery disease with 50% or greater diameter narrowing on CT-angiography
- Ability to understand risks, benefits, and treatment options and provide written informed consent
You will not qualify if you...
- Diagnosed or suspected acute coronary syndrome needing urgent hospitalization or testing
- High risk coronary artery disease including left main stenosis 50% or greater or significant three-vessel disease with 70% or greater narrowing
- Hemodynamically or clinically unstable conditions such as low blood pressure, ventricular arrhythmias, or persistent chest pain despite therapy
- Known coronary artery disease with prior myocardial infarction, percutaneous coronary intervention, or bypass surgery
- History of true anaphylaxis to contrast medium
- Significant congenital, severe valve, or cardiomyopathic diseases explaining cardiac symptoms
- Severe left ventricular dysfunction with ejection fraction less than 30%
- Intolerance to Aspirin, Clopidogrel, or Heparin
- Non-cardiac illnesses with life expectancy less than 2 years or likely to cause non-compliance
- Unwillingness or inability to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
SoonChunHyang University Hospital Bucheon
Bucheon-si, South Korea
Actively Recruiting
2
Kangwon National University Hospital
Chuncheon, South Korea
Actively Recruiting
3
Chungbuk National University Hospital
Chungju, South Korea
Actively Recruiting
4
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
5
Kyungpook National University Hospital
Daegu, South Korea
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6
Chungnam National University Hospital
Daejeon, South Korea
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7
Chonnam National University
Gwangju, South Korea
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8
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
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9
Inje university Ilsan Paik hospital
Ilsan, South Korea
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10
Gachon University Gil Medical Center
Incheon, South Korea
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11
Kwandong University Intl. ST. Mary's Hospital
Incheon, South Korea
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12
Gyeongsang National University Hospital
Jinju, South Korea
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13
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Actively Recruiting
14
Chung-Ang University Hospital
Seoul, South Korea
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15
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Actively Recruiting
16
Ewha Womans University Seoul Hospital
Seoul, South Korea
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17
Hanyang University Seoul Hospital, College of Medicine, Hanyang University
Seoul, South Korea
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18
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea
Actively Recruiting
19
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
20
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
21
Seoul National University Boramae Medical Center
Seoul, South Korea
Actively Recruiting
22
Ajou University Hospital
Suwon, South Korea
Actively Recruiting
Research Team
J
Joo Myung Lee, MD, MPH, PhD
CONTACT
D
David Hong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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