Acute Coronary Syndrome, Coronary Artery Disease, ST Elevation Acute Myocardial Infarction
Conditions
Keywords
radial access, primary angioplasty, trial, randomization, outcome
Brief summary
Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty
Detailed description
Prospective, randomized, double arm study. The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous coronary intervention, who agree and provide written informed consent for the study. Before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. Subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
Interventions
PROCEDUREFemoral approach
diagnostic and interventional procedures by femoral artery access
PROCEDURERadial approach
diagnostic and interventional procedures by radial artery access
Sponsors
Policlinico Casilino ASL RMB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is \>18 years old with recent acute ST-elevation acute coronary syndrome (STEACS) requiring emergent coronary angiography. 2. Patient has no contraindication to percutaneous arterial access by both and transfemoral route. 3. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site. 4. Patient and the treating physician agree that the subject will comply with all follow-up evaluations.
Exclusion criteria
1. Subject's age is \<18 years and he has no acute ST-elevation myocardial infarction (ST elevation of a least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads). 2. Subject has had a recent stroke or TIA (\<4 weeks), irrespective of age. 3. Patient has an international normalized ratio (INR) \> 2.0, or other severe bleeding diathesis 4. The patient is pregnant or breastfeeding. 5. Known allergies to: aspirin, clopidogrel and ticlopidine, heparin, IIb/IIIa inhibitors, stainless steel, or contrast agent (which cannot be adequately premedicated). 7.Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. 8.Prior participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Adverse Clinical Event | 30-day | Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net Adverse Clinical Event | 1-year | Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding |
| Individual components of NACE | 30-day | Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding |
| Total procedural and fluoroscopy times for the index procedure | 1 day | Comparison of procedural and fluoroscopy times between the two study groups |
| Hospital stay | 30-day | Days of hospitalization |
Countries
Italy
Outcome results
None listed