Arterial Access for Coronary Intervention in Myocardial Infarction
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Angioplasty, Transluminal, Percutaneous Coronary Myocardial Reperfusion |
Procedure: Coronary angioplasty |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction |
- 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 ]
- 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
| Enrollment: | 439 |
| Study Start Date: | May 2004 |
| Study Completion Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Spain | |
| Complexo Hospitalario Universitario de Santiago | |
| Santiago de Compostela, A Coruña, Spain, 15706 | |
| Hospital do Meixoeiro | |
| Vigo, Pontevedra, Spain, 36200 | |
| Hospital Juan Canalejo | |
| A Coruña, Spain, 15006 | |
| Study Chair: | Jose M Vazquez-Rodriguez, MD | Hospital Juan Canalejo |
| Principal Investigator: | Jose A Baz, Alonso | Hospital do meixoeiro |
| Study Director: | Andrés Iñiguez-Romo, MD | Hospital do Meixoeiro |
| Study Director: | Nicolás Vázquez-González, MD | Hospital Juan Canalejo |
| Principal Investigator: | Ramón Calviño-Santos, MD | Hospital Juan Canalejo |
| Study Director: | Antonio Amaro-Cendón, MD | Complejo Hospitalario Universitario de Santiago |
| Principal Investigator: | Ramiro Trillo, Nouche | Complejo Hospitalario Universitario de Santiago |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00356044 History of Changes |
| Other Study ID Numbers: | CEICG 2004/063 |
| Study First Received: | July 24, 2006 |
| Last Updated: | July 10, 2007 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Hospital Juan Canalejo:
|
Transradial access Femoral access Femoral vs radial access |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013