- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01996553
The Prevalence of Radial Artery Occlusion in Diagnostic Cardiac Catheterization and Percutaneous Intervention
The purpose of this study is to establish the rate of radial artery occlusion post transradial cardiac catheterization through different modalities.
The study hypothesis is that specialized imaging can provide specific information to help identify hand complications after cardiac catheterization through the wrist.
Study Overview
Status
Conditions
Detailed Description
The purpose of this study is to establish the rate of radial artery occlusion post diagnostic/interventional cardiac catheterization through different modalities, and to compare current assessment methods (such as Allen's test, Modified Barbeau test and duplex ultrasonography) to specialized imaging techniques for sensitivity and specificity of radial artery occlusion detection post transradial catheterization.
The study hypothesis is that specialized imaging can provide a specific focused analysis of hand characteristics to identify physiologic abnormalities as a result of radial artery occlusion post transradial catheterization.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Jesse Brown VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult subjects over the age of 18 who present to the Jesse Brown VA cath lab for a diagnostic radial artery angiogram or percutaneous intervention will be considered for the study.
Exclusion Criteria:
- Any subject who is unable to give informed consent or declines to participate will be excluded.
- Patients who have previously had a cardiac catheterization through the radial artery will be excluded because it will not be known if the changes to the circulation of the hand is secondary to the current or previous transradial catheterization.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Transradial cardiac catheterization
Patients undergoing cardiac catheterization through the radial artery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiologic abnormalities of the hand
Time Frame: 1 day to 3 weeks post transradial cardiac catheterization
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Blood flow to the hand in which transradial access was accomplished will be assessed for physiologic abnormalities as a result of radial artery occlusion post transradial catheterization
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1 day to 3 weeks post transradial cardiac catheterization
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Physiologic abnormalities of the hand
Time Frame: 3 weeks to 3 months post transradial cardiac catheterization
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Blood flow to the hand in which transradial access was accomplished will be assessed for physiologic abnormalities as a result of radial artery occlusion
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3 weeks to 3 months post transradial cardiac catheterization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radial Artery Occlusion
Time Frame: 1 day to 3 weeks post transradial catheterization
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Radial artery blood flow will be assessed for patency or occlusion 1 day to 3 weeks post transradial cardiac catheterization
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1 day to 3 weeks post transradial catheterization
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Radial Artery Occlusion
Time Frame: 3 weeks to 3 months post transradial catheterization
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Radial artery blood flow will be assessed for patency or occlusion 3 weeks to 3 months post transradial catheterization
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3 weeks to 3 months post transradial catheterization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katherine A Durham, MS, APN, Jesse Brown VA Medical Center
Publications and helpful links
General Publications
- Barbeau GR, Arsenault F, Dugas L, Simard S, Lariviere MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004 Mar;147(3):489-93. doi: 10.1016/j.ahj.2003.10.038.
- Durham KA. Cardiac catheterization through the radial artery. Am J Nurs. 2012 Jan;112(1):49-56. doi: 10.1097/01.NAJ.0000410370.81555.54. No abstract available.
- Dandekar VK, Vidovich MI, Shroff AR. Complications of transradial catheterization. Cardiovasc Revasc Med. 2012 Jan-Feb;13(1):39-50. doi: 10.1016/j.carrev.2011.08.005. Epub 2011 Nov 23.
- Sanmartin M, Gomez M, Rumoroso JR, Sadaba M, Martinez M, Baz JA, Iniguez A. Interruption of blood flow during compression and radial artery occlusion after transradial catheterization. Catheter Cardiovasc Interv. 2007 Aug 1;70(2):185-9. doi: 10.1002/ccd.21058.
- Bazemore E, Mann JT 3rd. Problems and complications of the transradial approach for coronary interventions: a review. J Invasive Cardiol. 2005 Mar;17(3):156-9. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 743024-6
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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