Comparing invasive and non-invasive diagnostic approaches for coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the clinical outcomes of invasive coronary angiography versus non-invasive functional tests in symptomatic patients with non-high risk obstructive coronary artery disease (CAD) confirmed by coronary computed tomography angiography (CCTA). It is a pragmatic, prospective, multi-center, open-label, randomized controlled trial designed to determine the most effective next step in diagnosis after CCTA. The study will assess the safety and efficacy of these approaches in a population that has been previously under-researched regarding follow-up diagnostics after CCTA. By comparing these two methods, the trial seeks to provide clearer guidelines for managing patients with obstructive CAD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject age ≥19 years old
2. Patients with new or worsening chest pain syndrome, equivalent symptoms, or abnormal laboratory test findings (suspected ischemic changes in electrocardiography, regional wall motion abnormality in echocardiography, or coronary calcium score \> 100) suspected for clinically significant CAD who are evaluated by CCTA
3. Any other clinical circumstance in which physician judged to proceed CCTA
4. Obstructive CAD in CCTA (≥50% diameter stenosis)
5. Subject who can verbally confirm understandings of risks, benefits, and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Exclusion Criteria:

1. Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing (elevated cardiac troponin or CK-MB)
2. High risk CAD (left main stenosis ≥ 50%; anatomically significant 3-vessel disease with ≥70% stenosis)
3. Hemodynamically or clinically unstable condition (systolic BP \< 90 mmHg, ventricular arrhythmias, or persistent resting chest pain in ischemic nature despite adequate therapy
4. Known CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)
5. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
6. Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms.
7. Severe left ventricular systolic dysfunction (ejection fraction \<30%)
8. Intolerance to Aspirin, Clopidogrel, or Heparin.
9. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
10. Unwillingness or inability to comply with the procedures described in this protocol.

Where it's running

• SoonChunHyang University Hospital Bucheon
  Bucheon-si, South Korea Recruiting
• Kangwon National University Hospital
  Chuncheon, South Korea Recruiting
• Chungbuk National University Hospital
  Chungju, South Korea Recruiting
• Keimyung University Dongsan Medical Center
  Daegu, South Korea Recruiting
• Kyungpook National University Hospital
  Daegu, South Korea Recruiting
• Chungnam National University Hospital
  Daejeon, South Korea Recruiting

Study contacts

• Principal investigator: Joo Myung Lee, MD, MPH, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, MPH, PhD
• Email: drone80@hanmail.net
• Phone: 82-2-3410-3391

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.