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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01019330
First received: November 20, 2009
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Radial Artery Occlusion
Other: Allen's test
Other: Distal pulses

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • To determine if there is a difference in complication rate measured at 30 days between radial and femoral catheterization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: June 2010
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Femoral
Subjects receiving femoral artery cardiac catheterization
Other: Distal pulses
Practitioner will check that the dorsalis pedis and posterior tibialis are palpable.
Radial
Subjects receiving radial artery cardiac catheterization
Other: Allen's test
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Male or Female
  • 19 years old or older
  • candidate for radial or femoral cardiac catheterization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019330

Contacts
Contact: Michael White, MD 402-280-4566 MichaelWhite@creighton.edu

Locations
United States, Nebraska
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131
The Cardiac Center at Creighton University Recruiting
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Michael White, MD Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01019330     History of Changes
Other Study ID Numbers: 09-15552
Study First Received: November 20, 2009
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
radial vs femoral
radial artery cardiac catheterization

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014