Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days

November 27, 2015 updated by: Creighton University
Cardiac catheterization has traditionally been performed via access to the arterial circulation from the femoral artery located in the groin. As an alternative to this approach, the radial artery, located in the arm, is gaining wider use in clinical practice. Multiple studies have demonstrated that cardiac catheterization via the radial approach has a very low complication rate, in the short term. This study is intended to determine if there are any differences in the long term complication rate between radial artery cardiac catheterization as compared with femoral artery cardiac catheterization.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

243

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

    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, United States, 68131
        • The Cardiac Center at Creighton University

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting at Creighton University Medical Center Cardiac Catheterization laboratory for either radial or femoral cardiac catherization

Description

Inclusion Criteria:

  • Male or Female
  • 19 years old or older
  • candidate for radial or femoral cardiac catheterization

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Femoral
Subjects receiving femoral artery cardiac catheterization
Practitioner will check that the dorsalis pedis and posterior tibialis are palpable.
Radial
Subjects receiving radial artery cardiac catheterization
The Allen's test checks to make sure that radial and ulnar arteries that supply blood to the hand are not blocked. A pulse oximeter is placed on the index finger of the hand. The subject is asked to make a fist for 10 seconds.At this time, pressure is applied over the ulnar and radial arteries as to occlude (block) both of them. The pulse oximeter reading will begin to fall. Radial arterial pressure is then released. If the artery is patent (working), the pulse oximeter reading will begin to rise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if there is a difference in complication rate measured at 30 days between radial and femoral catheterization
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Michael White, MD, Creighton University

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

June 1, 2010

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 27, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 09-15552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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