Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery S… (NCT05799092) | Clinical Trial Compass
RecruitingNot Applicable
Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
South Korea2,000 participantsStarted 2023-10-02
Plain-language summary
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).
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Subject age ≥19 years old
✓. 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
✓. Any other clinical circumstance in which physician judged to proceed CCTA
✓. Obstructive CAD in CCTA (≥50% diameter stenosis)
✓. 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
✕. Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing (elevated cardiac troponin or CK-MB)
✕. High risk CAD (left main stenosis ≥ 50%; anatomically significant 3-vessel disease with ≥70% stenosis)
✕. Hemodynamically or clinically unstable condition (systolic BP \< 90 mmHg, ventricular arrhythmias, or persistent resting chest pain in ischemic nature despite adequate therapy
✕. Known CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)
✕. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
What they're measuring
1
Time to first event of major adverse cardiac events (MACE)
Timeframe: 2 years after the last patient enrollment
✕. Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms.
✕. Severe left ventricular systolic dysfunction (ejection fraction \<30%)
✕. Intolerance to Aspirin, Clopidogrel, or Heparin.