Arterial Access for Coronary Intervention in Myocardial Infarction

Phase 4

Completed

• Conditions: Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Reperfusion

• Registration Number: NCT00356044
• Lead Sponsor: Hospital Juan Canalejo

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-05
• Study Completion: 2005-12
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-25
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-10
• Last Update Posted: 2007-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Hospital Juan Canalejo; 🇪🇸 A Coruña, Spain

Hospital do Meixoeiro; 🇪🇸 Vigo, Pontevedra, Spain

Complexo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, A Coruña, Spain