Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise.

The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.

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Detailed Description

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Conditions

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Exposure to Ionizing Radiation Coronary Heart Disease Vascular Access Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trans-radial access

Coronary angiography performed through trans-radial access

Group Type ACTIVE_COMPARATOR

Trans-radial

Intervention Type OTHER

Coronary angiography performed through trans-radial access

Trans-femoral access

Coronary angiography performed through trans-femoral access

Group Type ACTIVE_COMPARATOR

Trans-femoral

Intervention Type OTHER

Coronary angiography performed through trans-femoral access

Interventions

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Trans-radial

Coronary angiography performed through trans-radial access

Intervention Type OTHER

Trans-femoral

Coronary angiography performed through trans-femoral access

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Indication for a elective coronary angiography
* Eligible for either transfemoral or transradial approach
* Accept to sign the written consent form (WCF)

Exclusion Criteria

* Refusal to sign the WCF
* End stage renal failure
* Urgency/Emergency procedure
* Contraindication to perform both coronary and left ventricle angiogram
* Necessity of another vascular angiogram during coronary angiography

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No