Myocardial Infarction
Conditions
Brief summary
The objective of this study is to prospectively evaluate the outcomes of different treatment pathways using a Physiology & Imaging guided PCI in patients with STMEI. A multi-centre study that will prospectively enrol consecutive STEMI patients who don't receive primary PCI within 48 hours after symptom onset because of different reasons. STEMI patients with culprit lesion stenosis between 0%-90% will be included in this study and randomized to angiography-guided, FFR-guided or OCT guided PCI groups.
Interventions
PROCEDUREfunction or imaging guided PCI
FFR may be good tools to differentiate patients with STEMI who may not need stent implantation from those who need Optical coherence tomography (OCT) can visualize the microstructure of culprit and the OCT characteristics were validated by histology
Sponsors
Shenyang Northern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Age ≥18 years STEMI for 7-30 days Have not undergone PCI because: Stabilization in a non-PCI hospital followed by transfer to a tertiary hospital for further evaluation;Previous emergent angio without ballooning or stenting;Previous emergent Thrombus Aspiration without ballooning or stenting;Pharmacoinvasive therapy Stenosis between 0%-90% TIMI flow grad 3
Exclusion criteria
\- Left main disease or bypass disease Intolerance to a study drug, metal alloys, or contrast media Life expectancy less than one year Previous PCI or CABG history Cardiogenic shock or LVEF\<35% Severe renal or hepatic dysfunction, hemodynamic instability \>90% stenosis in culprit lesion TIMI flow ≤ grade 2 Planned surgery within 6 months after index procedure Clinical indications of inability to tolerate DAPT for 12 months Inability to provide written informed consent Participation in another trial before reaching the primary endpoint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year target lesion failure (TLF) | 12 month | a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Adverse Cardiovascular Events (MACE) | 12 month | Death from cardiac causes, ARC defined Stent Thrombosis, Non-fatal MI, Clinically driven target vessel revascularization (TVR) or re-hospitalization due to unstable or progressive angina |
Countries
China
Outcome results
None listed