Coronary Artery Disease
Conditions
Keywords
thrombectomy
Brief summary
Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue. Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain. Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.
Detailed description
The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI). Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution
Interventions
DRUGUrokinase
intracoronary, urokinase, 200,000 Units, bolus
DRUGSaline
intracoronary, saline, bolus 1 cc
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ST-elevation myocardial infarction * angiographic evidence of massive thrombosis in the culprit artery * Indication to manual thrombectomy followed by primary percutaneous coronary intervention (PCI) * Able to understand and willing to sign the informed CF
Exclusion criteria
* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcomes at 30 days | Up to 30 days | 30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial reperfusion after Primary CI | Up to 90 minutes after Primary PCI | ST-segment resolution (STR)\>70% as assessed 90 minutes after Primary PCI |
| Left ventricular remodeling | Up to 1 year after Primary PCI | A change in left ventricular end-diastolic volume\>20% (compared with baseline values) as assessed at 1-year echocardiography |
| 5-year MACE | Up to 5 years after Primary PCI | Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure |
Outcome results
None listed