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Compares treatment options for Coronary Artery Disease
Official title Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
ClinicalTrials.gov ID: NCT05799092
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Subject age ≥19 years old
- Patients with new or worsening chest pain syndrome, equivalent symptoms, or abnormal laboratory test findings (suspected ischemic changes in...
- 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...
You likely can't join if
- 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...
- 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)
- Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could...
See the full eligibility 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...
- 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...
- 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)
- 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.
- 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)
- Unwillingness or inability to comply with the procedures described in this protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Bucheon-si, South Korea
- Chuncheon, South Korea
- Chungju, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Gwangju, South Korea
- Gwangmyeong, South Korea
- Ilsan, South Korea
- Incheon, South Korea
- Jinju, South Korea
- Seongnam-si, South Korea
- Seoul, South Korea
- Suwon, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bucheon-si, South Korea; Chuncheon, South Korea; Chungju, South Korea; Daegu, South Korea; Daejeon, South Korea; Gwangju, South Korea and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.