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Arterial Access for Coronary Intervention in Myocardial Infarction

H

Hospital Juan Canalejo

Status and phase

Completed
Phase 4

Conditions

Angioplasty, Transluminal, Percutaneous Coronary
Myocardial Reperfusion
Myocardial Infarction

Treatments

Procedure: Coronary angioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00356044
CEICG 2004/063

Details and patient eligibility

About

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.

Full 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.

Enrollment

439 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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