Arterial Access for Coronary Intervention in Myocardial Infarction

NCT ID: NCT00356044

Last Updated: 2007-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 439 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2005-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Coronary angioplasty

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Juan Canalejo

OTHER

Sponsor Role: lead

Principal Investigators

Jose M Vazquez-Rodriguez, MD

Role: STUDY_CHAIR

Hospital Juan Canalejo

Jose A Baz, Alonso

Role: PRINCIPAL_INVESTIGATOR

Hospital do meixoeiro

Andrés Iñiguez-Romo, MD

Role: STUDY_DIRECTOR

Hospital do Meixoeiro

Nicolás Vázquez-González, MD

Role: STUDY_DIRECTOR

Hospital Juan Canalejo

Ramón Calviño-Santos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juan Canalejo

Antonio Amaro-Cendón, MD

Role: STUDY_DIRECTOR

Complejo Hospitalario Universitario de Santiago

Ramiro Trillo, Nouche

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Santiago

Locations

Hospital Juan Canalejo

A Coruña, A Coruña, Spain

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Hospital do Meixoeiro

Vigo, Pontevedra, Spain

Countries

Spain

References

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. doi: 10.1002/ccd.10493.

Reference Type: BACKGROUND

PMID: 12720237 (View on PubMed)

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. doi: 10.1016/j.ahj.2003.07.019.

Reference Type: BACKGROUND

PMID: 14691415 (View on PubMed)

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). Innovation in Intervention: i2 Summit 2007 Abstract Sessions. 10.1016/j.jacc.2007.01.048. J Am Coll Cardiol 2007;49(9_Suppl_B):12B.

Reference Type: RESULT

Other Identifiers

CEICG 2004/063

Identifier Type: -

Identifier Source: org_study_id