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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Jesse Brown VA Medical Center
Sponsor:
Information provided by (Responsible Party):
Katherine Durham RN, BSN, CCRN, Jesse Brown VA Medical Center
ClinicalTrials.gov Identifier:
NCT01996553
First received: November 22, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  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
Cardiac Catheterization
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 Jesse Brown VA Medical Center:

Primary Outcome Measures:
  • Radial Artery Occlusion [ Time Frame: 3 weeks to 3 months post transradial catheterization ] [ Designated as safety issue: No ]
    Radial artery blood flow will be assessed for patency or occlusion 3 weeks to 3 months post transradial cardiac catheterization


Secondary Outcome Measures:
  • Physiologic abnormalities of the hand [ Time Frame: 3 weeks to 3 months post transradial cardiac catheterization ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01996553

Contacts
Contact: Katherine A Durham, BSN 312-569-6610 Katherine.durham@va.gov
Contact: Mladen I Vidovich, MD 312-569-6610 miv@uic.edu

Locations
United States, Illinois
Jesse Brown VA Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Katherine A Durham, BSN    312-569-6610    Katherine.durham@va.gov   
Principal Investigator: Katherine A Durham, BSN         
Principal Investigator: Mladen I Vidovich, MD         
Sub-Investigator: Pouyan D Arman, MD         
Sponsors and Collaborators
Jesse Brown VA Medical Center
Investigators
Principal Investigator: Katherine A Durham, BSN 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: 2012-0941
Study First Received: November 22, 2013
Last Updated: November 22, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014