Arterial Access for Coronary Intervention in Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
Hospital Juan Canalejo
ClinicalTrials.gov Identifier:
NCT00356044
First received: July 24, 2006
Last updated: July 10, 2007
Last verified: July 2007
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
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:
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 August 28, 2014