NCT01996553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

4.3 years

First QC Date

November 22, 2013

Last Update Submit

August 8, 2017

Conditions

Keywords

blood flow, regionalcomplicationsdisease, arterial obstructivecardiac catheterizationradial artery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Radial Artery Occlusion

    1 day to 3 weeks post transradial catheterization

  • Radial Artery Occlusion

    3 weeks to 3 months post transradial catheterization

Study Arms (1)

Transradial cardiac catheterization

Patients undergoing cardiac catheterization through the radial artery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jesse Brown VA Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

  • 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.

    PMID: 14999199BACKGROUND
  • 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.

    PMID: 22222403BACKGROUND
  • 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.

    PMID: 22115936BACKGROUND
  • 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.

    PMID: 17203470BACKGROUND
  • 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.

    PMID: 15867445BACKGROUND

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Katherine A Durham, MS, APN

    Jesse Brown VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

November 22, 2013

First Posted

November 27, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations