None listed
Conditions
Interventions
Medical Device : Those who suspected of coronary artery disease, then treated coronary angiography (CCTA), and considered to get a coronary angiography (CAG) treatment needed will be selected as a par
s standard procedures. The procedures and the adverse effects will be recorded in the case record form(CRF).
CCTA images of the registrants will be provided to an independent CT core laboratory and Si
Sponsors
SiliconSapiens
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adult aged 19 and over 2. Person who voluntarily agreed to participate in this clinical trial and sign a written agreement. 3. Person who has = 64 Multi-detector row coronary CT angiography (CCTA) taken within 90 days before the treatment of coronary angiography 5. Person who needed to get a fractional flow reserve(FFR) test after the treatment of coronary angiography
Exclusion criteria
Exclusion criteria: 1. Patients requiring emergency treatment 2. Person who does not need to get a FFR test clinically because of total occlusion or near total occlusion in coronary angiogram. 3. Person who has difficulties in cooperation with medical staffs on accounts of such reasons as decrease in cognitive abilities. 4. Person who has experienced acute myocardial infarction within last 30 days 5. Person with Canadian Cardiovascular Society (CCS) Class IV and chest pain at rest 6. Patient with chronic kidney failure (Serum creatinine > 2.0 mg/dL) 7. Person with heart rate =100 beats / min 8. Person with systolic blood pressure =90 mmHg 9. Person with calcium levels = 1000 in CCTA images 10. Woman in pregnant 11. Person with body mass index > 35 kg/m2 12. Person who underwent percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) 13. Person who underwent artificial heart valve surgery 14. Person with complex congenital cardiac disease 15. Person with acute pulmonary edema 16. Person with an continuous unstable state including cardiac shock, sudden chest pain 17. Person with a cardiac lead such as pacemaker, implantable defibrillator, and cardiac resynchronization therapy 18. Person with hypersensitivity to beta-blockers, nitroglycerin, or adenosine 19. Person with hypersensitivity to contrast media 20. Person with clinically significant arrhythmia such as Complete AV block, Ventricular arrhythmia, etc. 21. Person in participating other clinical trials or have been a participant in other clinical trials within 30 days before screening 22. Person inappropriate to this clinical trial by the judgement of trial conductor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(Area under the receiver-operator characteristic curve) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Positive Predictive Value;Negative Predictive Value;analysis of correlation between invasive FFR and CT-FFR;Diagnostic accuracy | — |
Countries
Korea, Republic of
Contacts
Public ContactSi-Hyuk Kang
Seoul National University Bundang Hospital
Outcome results
None listed