Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab

Study Overview
=================
Brief Summary
-----------------
Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Using this modification of injection method the investigators can achieve less microvascular damage and a reduction of the infarct size with a significant improvement of the outcome at six months.

Detailed Description
-----------------
There are some evidence about the utilization of aspiration catheter (Indication class IIb with level of evidence B in European Guidelines) and intravenous abciximab (indication Class IIa an level of evidence A in European Guidelines) in primary PTCA. Direct intracoronary injection of abciximab get smaller infarct size than intravenous injection. The hypothesis of our study are that direct distal injection of abciximab by aspiration catheter will be better than proximal intracoronary injection with reduction in infarct size and microvascular damage quantified by Magnetic resonance (MR) and 6 months mortality.

Official Title
-----------------
Phase 4 Study of Primary Angioplasty Combined Distal Injection of Abciximab to Thrombus and Aspiration With Catheter

Conditions
-----------------
Myocardial Infarction, Occlusive Thrombus

Intervention / Treatment
-----------------
* Other: Intracoronary direct injection
* Other: Intracoronary and distal injection by aspiration device
* Other: Intracoronary distal injection by aspiration catheter device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myocardial infarction patients between 3 and 12 hours after symptoms onset Exclusion Criteria: Hemodynamic instability TIMI flow 2 or 3 Life expectance less than 6 months Contraindication to AAS, clopidogrel or abciximab Severe tortuosity of occluded vessel

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP A<br>Intracoronary full bolus dose of abciximab proximal to thrombus occlusion | Other: Intracoronary direct injection<br>* Abciximab bolus dosage: 0,125 mg/kg. Group A: Intracoronary full bolus dose of abciximab proximal to thrombus occlusion. The investigators inject the bolus of abciximab by catheter guide before cross the occlusion. This in the normal way in study' laboratory.<br>* Other names: Abciximab, thrombus aspiration catheter;|
| Experimental: GROUP B<br>Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter | Other: Intracoronary and distal injection by aspiration device<br>* Abciximab bolus dosage: 0,125 mg/kg. Group B: Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter. The investigators inject half of the dose like group A and the other half like group C.<br>* Other names: Abciximab, thrombus aspiration catheter;|
| Experimental: GROUP C<br>Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter | Other: Intracoronary distal injection by aspiration catheter device<br>* Abciximab bolus dosage: 0,125 mg/kg. Group C: Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter. The investigators inject the bolus after cross the occlusion using an aspiration catheter.<br>* Other names: Abciximab, thrombus aspiration catheter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size | Infarct size quantified by MR | Between 2 and 9 days after primary ptca | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) | Cardiac mortality, reinfarction, new revascularization, and stroke | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary PTCA, Thrombus Aspiration Catheter, Intracoronary Abciximab