Physiology & Optical Coherence in STEMI

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Evaluation of Clinical Impact of Physiology & Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCI

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: function or imaging guided PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: angiography-guided PCI<br> | Procedure: function or imaging guided PCI<br>* 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<br>|
| Experimental: FFR-guided PCI<br> | Procedure: function or imaging guided PCI<br>* 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<br>|
| Experimental: OCT-guided PCI<br> | Procedure: function or imaging guided PCI<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year target lesion failure (TLF) | a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR). | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major Adverse Cardiovascular Events (MACE) | 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 | 12 month |