Coronary versus Intravenous abCiximab administration during Emergency Reperfusion Of ST-segment elevation myocardial infarction - the CICERO trial

Phase 4

Recruiting

Conditions: acute myocardial infarction
heart attack
10011082

Registration Number: NL-OMON32667

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 530

Inclusion Criteria

- a diagnosis of STEMI defined by
a. chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
b. time from onset of symptoms of less than 12 hours
c. ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads
- primary PCI performed
- verbal followed by written informed consent

Exclusion Criteria

-rescue PCI after thrombolytic therapy
-need for emergency coronary artery bypass grafting
-presence of cardiogenic shock
-known existence of a life-threatening disease with a life expectancy of less than 6 months
-inability to provide informed consent
-age below 18 years
-Contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensie or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is >70% ST-segment elevation resolution, a marker of<br /><br>myocardial perfusion. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary end points are electrocardiographic and angiographic measures of<br /><br>myocardial reperfusion, infarct size, and clinical outcome at 30 days and 1<br /><br>year. </p><br>