Myocardial Infarction, Occlusive Thrombus
Conditions
Keywords
Primary PTCA, Thrombus Aspiration Catheter, Intracoronary Abciximab
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.
Interventions
OTHERIntracoronary direct injection
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.
OTHERIntracoronary and distal injection by aspiration device
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.
OTHERIntracoronary distal injection by aspiration catheter device
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.
Sponsors
Hospital Virgen de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size | Between 2 and 9 days after primary ptca | Infarct size quantified by MR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 6 months | Cardiac mortality, reinfarction, new revascularization, and stroke |
Countries
Spain
Contacts
Primary ContactJose Moreu, MD,PhD
Backup ContactFernando Pajin, MD
Outcome results
None listed