NCT Number: NCT00356044
Arterial Access for Coronary Intervention in Myocardial Infarction
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.
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Hospital Juan Canalejo, A Coruña, Spain
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
All cause mortality at 30 days
Time frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
-
New ST elevation acute myocardial infarction at 30 days
Time frame: 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
Time frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
-
Major vascular complications at 30 days.
Time frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Secondary outcomes
-
Embolic stroke at 30 days
Time frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
-
Coronary revascularization at 30 days
Time frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
-
Cardiovascular mortality at 30 days
Time frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction
-
Procedural time
-
Hospital stay
-
Estimation of costs
Sponsors and collaborators
Lead sponsor
Hospital Juan Canalejo
Other
Registry information
Official study title
Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction
Important dates
- Study start
- 2004
- Study completion
- 2005
- First posted
- Jul 25, 2006
- Registry last updated
- Jul 11, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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