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Arterial Access for Coronary Intervention in Myocardial Infarction

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Coronary angioplasty
Sponsored by
Hospital Juan Canalejo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Transradial access, Femoral access, Femoral vs radial access

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Complexo Hospitalario Universitario de Santiago
  • Hospital do Meixoeiro
  • Hospital Juan Canalejo

Outcomes

Primary Outcome Measures

All cause mortality at 30 days
New ST elevation acute myocardial infarction at 30 days
Coronary revascularization as a result of recurrent ischemia at 30 days
Major vascular complications at 30 days.

Secondary Outcome Measures

Embolic stroke at 30 days
Coronary revascularization at 30 days
Cardiovascular mortality at 30 days
Procedural time
Hospital stay
Estimation of costs

Full Information

First Posted
July 24, 2006
Last Updated
July 10, 2007
Sponsor
Hospital Juan Canalejo
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1. Study Identification

Unique Protocol Identification Number
NCT00356044
Brief Title
Arterial Access for Coronary Intervention in Myocardial Infarction
Official Title
Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Juan Canalejo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Reperfusion
Keywords
Transradial access, Femoral access, Femoral vs radial access

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Coronary angioplasty
Primary Outcome Measure Information:
Title
All cause mortality at 30 days
Time Frame
within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Title
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
Title
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
Title
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 Measure Information:
Title
Embolic stroke at 30 days
Time Frame
within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Title
Coronary revascularization at 30 days
Time Frame
within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Title
Cardiovascular mortality at 30 days
Time Frame
within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Title
Procedural time
Title
Hospital stay
Title
Estimation of costs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Vazquez-Rodriguez, MD
Organizational Affiliation
Hospital Juan Canalejo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose A Baz, Alonso
Organizational Affiliation
Hospital do meixoeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrés Iñiguez-Romo, MD
Organizational Affiliation
Hospital do Meixoeiro
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nicolás Vázquez-González, MD
Organizational Affiliation
Hospital Juan Canalejo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ramón Calviño-Santos, MD
Organizational Affiliation
Hospital Juan Canalejo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Amaro-Cendón, MD
Organizational Affiliation
Complejo Hospitalario Universitario de Santiago
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ramiro Trillo, Nouche
Organizational Affiliation
Complejo Hospitalario Universitario de Santiago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complexo Hospitalario Universitario de Santiago
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital do Meixoeiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Facility Name
Hospital Juan Canalejo
City
A Coruña
ZIP/Postal Code
15006
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
12720237
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. doi: 10.1002/ccd.10493.
Results Reference
background
PubMed Identifier
14691415
Citation
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.
Results Reference
background
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). 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.
Results Reference
result

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Arterial Access for Coronary Intervention in Myocardial Infarction

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