Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.

Detailed Description
-----------------
Intravascular ultrasound (IVUS) has been increasingly used as a guide for percutaneous coronary intervention (PCI) during elective as well as emergent clinical scenario. Recent small number randomized studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of IVUS-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization. There are sparse data available on the clinical impact of IVUS-guided PCI in the setting of acute myocardial infarction (AMI) and its use remains a matter of controversy as shown by previous studies. This study is to examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction (STEMI).

Official Title
-----------------
A Prospective, Open Label, Multicenter and Randomized Study of Clinical Outcomes of Intravascular Ultrasound -Guided and Angiography-Guided Primary Percutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction

Conditions
-----------------
ST Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: IVUS-guided PCI
* Procedure: Angiography-guided PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical inclusion criteria: Age > 18 years Onset of STEMI > 30 minutes, but < 12 hours ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG Willing and able to provide informed consent Angiographic inclusion criteria: Having at least one infarct-related coronary artery, of which (1) the Culprit lesion is suitable for stenting (2) the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm (3) the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation Exclusion Criteria: Clinical exclusion criteria: Contraindicating to any concomitant study medications Having cardiogenic shock with hemodynamic instability A history of bleeding diathesis or known coagulopathy A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count < 100,000 /mm3 or Hb < 10 g/dL Planned surgery which may cause discontinuation of ADP-receptor antagonist Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year Repeated MI within 7 days of hospitalization for acute MI Anigographic Exclusion Criteria: Bifurcated lesion unable to identify the culprit lesion The culprit lesion is located in the left main artery Diffusive lesions without distinguishable culprit lesion Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis Likely CABG procedure within 30 days Renal failure requiring or during dialysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS-guided PCI<br>Percutaneous intervention under IVUS-guidance | Procedure: IVUS-guided PCI<br>* Performing intravascular ultrasound before or/and after percutaneous intervention<br>|
| Active Comparator: Angiography-guided PCI<br>Percutaneous intervention under angiograhy-guidance only | Procedure: Angiography-guided PCI<br>* Performing percutaneous intervention without intravascular ultrasound guidance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac event (MACE) rate | Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE rate |  | 2-3 years | 
| Target lesion revascularization (TLR) rate |  | 2-3 years | 
| Target lesion failure (TLF) rate |  | 2-3 years | 
| TVR rate |  | 2-3 years | 
| Target vessel failure (TVF) rate |  | 2-3 years | 
| MI (Q-wave and non-Q-wave) rat |  | 2-3 years | 
| Cardiac death rate |  | 2-3 years | 
| Non-cardiac death rate |  | 2-3 years | 
| All death (cardiac and non-cardiovascular) rate |  | 2-3 years | 
| Stent Thrombosis (ST) rate (ARC definite/probable) |  | 2-3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, Intravascular ultrasound, Angiography, Primary percutaneous intervention