Complete Infarct Related Artery Revascularization

Study Overview
=================
Brief Summary
-----------------
CORAMI trial is a prospective, international, multicenter randomized study which will be performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary intervention) duty and patient enrollment will continue for 18 months (October 2010 - March 2012).The aim of the study is to compare strategy of complete vs target lesion-only primary PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.

Official Title
-----------------
Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial

Conditions
-----------------
Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: IRA stenting in culprit lesion only
* Procedure: IRA stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of STEMI (according to ESC 2007 definition) Chest pain onset <12 hours signed informed consent Presence of two critical lesions requiring PCI in IRA (LAD - left anterior descending, Cx - circumflex, RCA - right coronary artery) Target/culprit lesion which requires immediate stenting (>50 - 100%) and second critical lesion (70-90%) with TIMI 3 flow after PCI of the 1st target/culprit lesion Over 18 years of age IRA diameter ≥ 2.5 mm Exclusion Criteria: Terminal illness with life expectancy less <1 year or active cancer disease - Pregnancy or possibility of pregnancy Second critical lesion in IRA >90% or occlusion Contraindications to PCI or/and stent implantation Contraindications to DES stent implantation Lesion diameters unsuitable for intended stent platform Active bleeding or coagulopathy Patient in cardiogenic shock (<90mmHg SBP and/or requiring IABP - intraaortic balloon pump - or vasopressors) - Killip 4 class Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm No future patient cooperation expected Patient is participating in another clinical study

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: Culprit lesion IRA Revascularization<br>Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES | Procedure: IRA stenting in culprit lesion only<br>* stenting<br>|
| Active Comparator: Complete IRA revascularization<br>Primary PCI of culprit lesion in IRA with DES stent | Procedure: IRA stenting<br>* Complete IRA revascularization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade) | This is a combined end-point of ST - segment resolution >70% assessed directly after PCI + MBG 3 assessed directly after PCI (assessments by ECG and QCA Corelab). | in-hospital directly after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical major ischemic events | Death at 12-month clinical follow-up Stent thrombosis at 12-month follow-up according to ARC definition reMI at 12 months urgent TVR at 12 months | 12-months | 
| Adverse events and complications during hospital stay | Immediate in-hospital angiographic complications (at least one or more of the following: distal embolisation, no-reflow, slow-flow, acute coronary artery occlusion,artery perforation, tamponade, dissection type B and above) urgent in-hospital Target Vessel Revascularization (PCI and/or CABG - coronary artery bypass graft) | during patient index hospitalization (up to 7 days) |