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The Prevalence of Radial Artery Occlusion in Diagnostic Cardiac Catheterization and Percutaneous Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996553
First Posted: November 27, 2013
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Katherine Durham RN, BSN, CCRN, Jesse Brown VA Medical Center
  Purpose

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.


Condition
Coronary Angiography Radial Artery Occlusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prevalence of Radial Artery Occlusion in Diagnostic Cardiac Catheterization and Percutaneous Intervention

Further study details as provided by Katherine Durham RN, BSN, CCRN, Jesse Brown VA Medical Center:

Primary Outcome Measures:
  • Physiologic abnormalities of the hand [ Time Frame: 1 day to 3 weeks post transradial cardiac catheterization ]
    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

  • Physiologic abnormalities of the hand [ Time Frame: 3 weeks to 3 months post transradial cardiac catheterization ]
    Blood flow to the hand in which transradial access was accomplished will be assessed for physiologic abnormalities as a result of radial artery occlusion


Secondary Outcome Measures:
  • Radial Artery Occlusion [ Time Frame: 1 day to 3 weeks post transradial catheterization ]
    Radial artery blood flow will be assessed for patency or occlusion 1 day to 3 weeks post transradial cardiac catheterization

  • Radial Artery Occlusion [ Time Frame: 3 weeks to 3 months post transradial catheterization ]
    Radial artery blood flow will be assessed for patency or occlusion 3 weeks to 3 months post transradial catheterization


Enrollment: 172
Study Start Date: April 2013
Study Completion Date: July 2017
Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Transradial cardiac catheterization
Patients undergoing cardiac catheterization through the radial artery.

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects consist of patients who present to the cardiac catheterization laboratory for an angiogram or percutaneous intervention for the first time.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996553


Locations
United States, Illinois
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Jesse Brown VA Medical Center
Investigators
Principal Investigator: Katherine A Durham, MS, APN Jesse Brown VA Medical Center
  More Information

Publications:
Responsible Party: Katherine Durham RN, BSN, CCRN, Registered Nurse, Jesse Brown VA Medical Center
ClinicalTrials.gov Identifier: NCT01996553     History of Changes
Other Study ID Numbers: 743024-6
First Submitted: November 22, 2013
First Posted: November 27, 2013
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by Katherine Durham RN, BSN, CCRN, Jesse Brown VA Medical Center:
blood flow, regional
complications
disease, arterial obstructive
cardiac catheterization
radial artery

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