Arterial Access for Coronary Intervention in Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356044
• Other study ID #: CEICG 2004/063
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2006
• Last updated: July 10, 2007
• Start date: May 2004
• Est. completion date: December 2005

Study information

• Verified date: July 2007
• Source: Hospital Juan Canalejo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Coronary angioplasty

Locations

Country	Name	City	State
Spain	Hospital Juan Canalejo	A Coruña
Spain	Complexo Hospitalario Universitario de Santiago	Santiago de Compostela	A Coruña
Spain	Hospital do Meixoeiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juan Canalejo

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Exaire JE, Dauerman HL, Topol EJ, Blankenship JC, Wolski K, Raymond RE, Cohen EA, Moliterno DJ; TARGET Investigators. Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am Heart J. 2004 Jan;147(1):31-4. — View Citation

Saito S, Tanaka S, Hiroe Y, Miyashita Y, Takahashi S, Tanaka K, Satake S. Comparative study on transradial approach vs. transfemoral approach in primary stent implantation for patients with acute myocardial infarction: results of the test for myocardial infarction by prospective unicenter randomization for access sites (TEMPURA) trial. Catheter Cardiovasc Interv. 2003 May;59(1):26-33. — View Citation

Vazquez Rodriguez JM, Calvino Santos R, Baz Alonso JA, Trillo Nouche R, Salgado Fernandez J, Sanmartin Fernandez M, et al. Radial vs. Femoral access in emergent coronary interventions for acute myocerdial infarction with ST segment elevation (abstract). I

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality at 30 days		within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Primary	New ST elevation acute myocardial infarction at 30 days		within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Primary	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
Primary	Major vascular complications at 30 days.		within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Secondary	Embolic stroke at 30 days		within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Secondary	Coronary revascularization at 30 days		within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Secondary	Cardiovascular mortality at 30 days		within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Secondary	Procedural time
Secondary	Hospital stay
Secondary	Estimation of costs