Clinical trial NCT01996553: The Prevalence of Radial Artery Occlusion in Diagnostic Cardiac Catheterization and Percutaneous Intervention
Official title: The Prevalence of Radial Artery Occlusion in Diagnostic Cardiac Catheterization and Percutaneous Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Angiography
Radial Artery Occlusion
Keywords: blood flow, regional
complications
disease, arterial obstructive
cardiac catheterization
radial artery
Lead sponsor: Jesse Brown VA Medical Center
Sponsor class: FED
First posted: 2013-11-27
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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.

Primary outcomes:
measure: Physiologic abnormalities of the hand
timeFrame: 1 day to 3 weeks post transradial cardiac catheterization
measure: Physiologic abnormalities of the hand
timeFrame: 3 weeks to 3 months post transradial cardiac catheterization
Secondary outcomes:
measure: Radial Artery Occlusion
timeFrame: 1 day to 3 weeks post transradial catheterization
measure: Radial Artery Occlusion
timeFrame: 3 weeks to 3 months post transradial catheterization
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
Study officials:
affiliation: Jesse Brown VA Medical Center
name: Katherine A Durham, MS, APN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. No abstract available.
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.
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. doi: 10.1002/ccd.21058.
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. No abstract available.