Arterial Access for Coronary Intervention in Myocardial Infarction

Study Overview
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Brief Summary
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The aim of this study is to compare the radial and femoral access for percutaneous interventions in the acute phase of the ST elevation acute myocardial infarction in terms of efficacy and security.

Detailed Description
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Some groups have previously used the radial artery as the access route in the procedures of percutaneous coronary revascularization, with good results. The advantages of the radial compared with femoral access are related to a lower incidence of vascular complications. The radial access has also inconveniences such as a less predictable anatomy which can make the procedure difficult and prolong the time required.The patients with ST elevation myocardial infarction have an increased risk of vascular complications after interventional procedures because previous antithrombotic or thrombolytic therapy.On the other hand, the time and success of the procedure are significant prognostic issues.In this sitting, the radial approach might reduce vascular complications and increase other cardiovascular events when comparing with the classical femoral access. For this reason, the purpose of the study is to compare both arterial access in terms of efficacy and security and to quantify the consequences of the advantages and drawbacks of both.

Official Title
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Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction

Conditions
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Myocardial Infarction, Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Reperfusion

Intervention / Treatment
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* Procedure: Coronary angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ST elevation acute myocardial infarction referred for primary,facilitated or of rescue coronary angioplasty in the first 12 hours since the start of the symptoms. Exclusion Criteria: Patients in cardiogenic shock were excluded following operator criteria. Previous coronary surgery with mammary artery graft Coronary artery intervention in the previous month Absolute or relative contraindication for access via the radial artery route:Radial pulse absent or weak, abnormal Allen test,anatomy known to impede the use of the radial route or hemodialysis or advanced chronic renal insufficiency (creatinine >3 mg/dl). Patients with absolute or relative contraindication for the use of the femoral route. Absence of informed consent from the patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Coronary angioplasty|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality at 30 days |  | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | 
| New ST elevation acute myocardial infarction at 30 days |  | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | 
| Coronary revascularization as a result of recurrent ischemia at 30 days |  | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | 
| Major vascular complications at 30 days. |  | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embolic stroke at 30 days |  | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | 
| Coronary revascularization at 30 days |  | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | 
| Cardiovascular mortality at 30 days |  | within the first 30 days (plus or minus 5 days) after the index myocardial infarction | 
| Procedural time |  |  | 
| Hospital stay |  |  | 
| Estimation of costs |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transradial access, Femoral access, Femoral vs radial access