acute myocardial infarction
Conditions
Interventions
Test group: opitical coherence tomography-guided percutaneous coronary intervention
Control group: intravascular ultrasound-guided percutaneous coronary intervention
Sponsors
Shinke Toshiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject age >= 18 years old 2.AMI diagnosed within 24 hours from the onset of ischemic symptoms 3.Identification of the culprit lesion and the indication for emergency PCI under intravascular imaging guidance
Exclusion criteria
Exclusion criteria: 1.Unable or unwilling to provide written informed consent from the participant or their legally acceptable representative 2.No indication for any PCI 3.Known severe renal dysfunction (serum creatinine >2.0 mg/dL) 4.Renal replacement therapy 5.Cardiogenic shock (Killip IV) 6.Previous coronary artery bypass graft surgery 7.Estimated life expectancy <1 year 8.Left main coronary artery lesion 9.Right coronary artery ostium lesion 10.Anticipated inability to cross the intravascular imaging catheter or difficulty in image acuisition due to severe calcification, tortuosity or dilation 11.Chronic total occlusion lesion 12.Any prior PCI within 1 month 13.Contraindication to antiplatelet agent or heparin 14.Pregnancy or breast feeding 15.Unwillingness or inability to comply with the requirements of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-inferiority of the OCT-guided PCI compered to IVUS guided PCI in terms of target vessel failure (TVF) at a median follow-up of 1.5 years after randomization in the study population. - TVF is defined as composite time-to-first event rate of cardiac death, target vessel* myocardial infarction, or ischemia-driven target vessel revascularization (ID-TVR). *Target vessel: vessels treated for both the culprit lesion of AMI and a non-culprit lesion (planned to be treated within 3 months from the index PCI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes 1)Individual components of primary endpoint 2)All-cause death 3)Cardiac and non-cardiac death 4)Any myocardial infarction 5)Definite/probable stent thrombosis (ARC definition) 6)Stroke 7)Any revascularization 8)ID-revascularization and non-ID-revascularization 9)ID-TVR, ID-TLR and ID-non-TLR TVR 10)Bleeding 11)Relationship between post-PCI OCT/IVUS parameters and clinical endpoint rates Procedure outcomes 1)Achievement rate of TIMI grade 3 flow 2)Rate of achieving optimal imaging criteria 3)Rate of stentless procedure 4)Imaging performance success Safety outcomes 1)Contrast induced nephropathy 2)Procedure time, fluoroscopy time, radiation dose, and quantity of contrast medium 3)Imaging related or non-related procedural complications (coronary perforation, coronary dissection, distal embolization, side branch occlusion, ventricular fibrillation or tachycardia during procedure, stroke during procedure). | — |
Countries
Japan, Undetermined
Contacts
Public ContactKoshiro Sakai
Showa Medical University
Outcome results
None listed