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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01996553
Other study ID # 743024-6
Secondary ID
Status Completed
Phase N/A
First received November 22, 2013
Last updated August 8, 2017
Start date April 2013
Est. completion date July 2017

Study information

Verified date August 2017
Source Jesse Brown VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States Jesse Brown VA Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Jesse Brown VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Barbeau GR, Arsenault F, Dugas L, Simard S, Larivière 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physiologic abnormalities of the hand 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 1 day to 3 weeks post transradial cardiac catheterization
Primary Physiologic abnormalities of the hand Blood flow to the hand in which transradial access was accomplished will be assessed for physiologic abnormalities as a result of radial artery occlusion 3 weeks to 3 months post transradial cardiac catheterization
Secondary Radial Artery Occlusion Radial artery blood flow will be assessed for patency or occlusion 1 day to 3 weeks post transradial cardiac catheterization 1 day to 3 weeks post transradial catheterization
Secondary Radial Artery Occlusion Radial artery blood flow will be assessed for patency or occlusion 3 weeks to 3 months post transradial catheterization 3 weeks to 3 months post transradial catheterization
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