ST-Elevation Myocardial Infarction Clinical Trial
— CICEROOfficial title:
Coronary Versus Intravenous abCiximab Administration During Emergency Reperfusion Of ST-segment Elevation Myocardial Infarction - the CICERO Trial
The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Status | Active, not recruiting |
Enrollment | 534 |
Est. completion date | April 2011 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: a diagnosis of STEMI defined by - chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission - time from onset of symptoms of less than 12 hours - ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads 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 - 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, hypertensive or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Centre Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of ST-segment resolution >70% | 30 to 60 minutes post-PCI | No | |
Secondary | Bleeding complications | in-hospital | Yes | |
Secondary | Thrombolysis In Myocardial Infarction (TIMI) flow | post-PCI | No | |
Secondary | Myocardial Blush Grade (MBG) | post-PCI | No | |
Secondary | Incidence of distal embolization | post-PCI | No | |
Secondary | persistent residual ST-segment deviation | 30 to 60 minutes post-PCI | No | |
Secondary | enzymatic infarct size | in-hospital | No | |
Secondary | Major Adverse Cardiac Events (MACE) | 30 days | No |
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