None listed
Conditions
Interventions
Others : The aim of the study is to compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive coronary arte
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Inclusion criteria 1) 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) suspicious for clinically significant CAD who are evaluated by CCTA 2) Any other clinical circumstance in which physician judged to proceed CCTA 3) Patients who are with Intermediate to high pretest probabilities of obstructive CAD (pre-test probability >15%) and evaluated by 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
Exclusion criteria: (2) 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 myocardial infarction (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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first event of major adverse cardiac events (MACE, a composite of death, MI, resuscitated cardiac arrest, clinically driven unplanned revascularization), according to the Academic Research Consortium (ARC) II-consensus. | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death;Cardiac death;Any MI, defined by Forth Universal definition of MI;Spontaneous MI, defined by Forth Universal definition of MI;Procedure-related MI, defined by ARC II definition;Resuscitated cardiac arrest;Unplanned revascularization (clinically driven);Rate of index coronary angiography;Rate of index revascularization by PCI or CABG;European Quality of Life-5 Dimensions (EQ-5D-5L) (quality of life);Seattle Angina Questionnaire (SAQ) (angina severity);Total medical cost | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo Myung Lee
Samsung Medical Center
Outcome results
None listed