Radial Artery OcclusionNCT01019330
Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days
An observational study of Radial Artery Occlusion, run by Creighton University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Radial Artery Occlusion
- What is being tested?
- Allen's test and Distal pulses
- How many people
- 243 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting at Creighton University Medical Center Cardiac Catheterization laboratory for either radial or femoral cardiac catherization
Who may be able to join
- Male or Female
- 19 years old or older
- candidate for radial or femoral cardiac catheterization
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Creighton University Medical Center
Omaha, Nebraska, 68131
The Cardiac Center at Creighton University
Omaha, Nebraska, 68131
About this study
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.
- Conditions
- Radial Artery Occlusion
- Being tested
- Allen's test, Distal pulses
- Keywords
- radial vs femoral, radial artery cardiac catheterization
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allen's testOther
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.
Distal pulsesOther
Practitioner will check that the dorsalis pedis and posterior tibialis are palpable.
| Study group | Role | What they receive |
|---|---|---|
| Femoral | Subjects receiving femoral artery cardiac catheterization Receives: Other: Distal pulses | |
| Radial | Subjects receiving radial artery cardiac catheterization Receives: Other: Allen's test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if there is a difference in complication rate measured at 30 days between radial and femoral catheterization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJun 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael White, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019330
- Sponsor's protocol ID
- 09-15552
- Status last verified
- Nov 2015
- First submitted
- 20 Nov 2009
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Versus Femoral Arterial Access for Cardiac Catheterization: Comparison of Complications at 30 Days
- ClinicalTrials.gov ID
- NCT01019330
- Acronym / sponsor ID
- 09-15552
- Conditions
- Radial Artery Occlusion
- Keywords
- radial vs femoral, radial artery cardiac catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral | – | Other: Distal pulsesSubjects receiving femoral artery cardiac catheterization |
| Radial | – | Other: Allen's testSubjects receiving radial artery cardiac catheterization |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at Creighton University Medical Center Cardiac Catheterization laboratory for either radial or femoral cardiac catherization
Key inclusion criteria (3 listed)
- Male or Female
- 19 years old or older
- candidate for radial or femoral cardiac catheterization
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allen's testThe 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. | Other | Radial |
| Distal pulsesPractitioner will check that the dorsalis pedis and posterior tibialis are palpable. | Other | Femoral |
Primary outcome
To determine if there is a difference in complication rate measured at 30 days between radial and femoral catheterization
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael White, MD principal investigator
Creighton University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Artery Occlusion, run by Creighton University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if there is a difference in complication rate measured at 30 days between radial and femoral catheterization (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.