NCT01019330

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

5.2 years

First QC Date

November 20, 2009

Last Update Submit

November 27, 2015

Conditions

Keywords

radial vs femoralradial artery cardiac catheterization

Outcome Measures

Primary Outcomes (1)

  • To determine if there is a difference in complication rate measured at 30 days between radial and femoral catheterization

    30 days

Study Arms (2)

Femoral

Subjects receiving femoral artery cardiac catheterization

Other: Distal pulses

Radial

Subjects receiving radial artery cardiac catheterization

Other: Allen's test

Interventions

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.

Radial

Practitioner will check that the dorsalis pedis and posterior tibialis are palpable.

Femoral

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

The Cardiac Center at Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Michael White, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 25, 2009

Study Start

June 1, 2010

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations