Arterial Access for Coronary Intervention in Myocardial Infarction - Full Text View

Sponsored by:	Hospital Juan Canalejo
Information provided by:	Hospital Juan Canalejo
ClinicalTrials.gov Identifier:	NCT00356044

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 IV

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction

Further study details as provided by Hospital Juan Canalejo:

Primary Outcome Measures:

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 Outcome Measures:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356044

Locations

Spain
Hospital Juan Canalejo
A Coruña, Spain, 15006
Spain, A Coruña
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Spain, Pontevedra
Hospital do Meixoeiro
Vigo, Pontevedra, Spain, 36200

Sponsors and Collaborators

Hospital Juan Canalejo

Investigators

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 of Results:

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.

Other Publications:

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.

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.

Study ID Numbers:	CEICG 2004/063
Study First Received:	July 24, 2006
Last Updated:	July 10, 2007
ClinicalTrials.gov Identifier:	NCT00356044
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Juan Canalejo:

Transradial access
Femoral access
Femoral vs radial access

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 11, 2009