Coronary angioplasty in Myocardial Infarction and Angioplasty, Transluminal, Percutaneous Coronary and Myocardial Reperfusion - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Coronary angioplasty

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.

Study Type

Interventional

Enrollment (Actual)

439

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality at 30 days Time Frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction	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	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	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	within the first 30 days (plus or minus 5 days) after the index myocardial infarction

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital stay
Embolic stroke at 30 days Time Frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction	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	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	within the first 30 days (plus or minus 5 days) after the index myocardial infarction
Procedural time
Estimation of costs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1002/ccd.10493.
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.
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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria