Smartphone Assessment Prior Radial Artery Harvesting for CABG

Coronary Artery Disease Clinical Trial

— iRADIAL-CABG  

Official title:

Utility of a Smartphone Application in Assessing Palmar Circulation Prior to Radial Artery Harvesting for Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810729
• Other study ID #: 20180865-01H
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: August 8, 2022

Study information

• Verified date: October 2022
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Coronary artery bypass graft (CABG) surgery is a procedure where surgeons use blood vessels from elsewhere in the body to go around blockages or narrowings in the heart arteries. Before the surgery, the surgeon needs to choose which vessel will be used for the bypass, including potentially the radial artery in the wrist. Smartphones have been shown in a previous study to be a better way to assess the arteries in the hand than the traditional physical examination, as it is less subjective than simply watching the flushing of the hand. In this study, the investigators will assess the utility of a smartphone application in determining whether there is enough blood flow in the hand prior to using the radial artery for CABG surgery.

Description:

Coronary artery bypass graft (CABG) surgery is a procedure where surgeons use blood vessels from elsewhere in the body to go around blockages or narrowings in the heart arteries. Before the surgery, the surgeon needs to choose which vessel will be used for the bypass, including potentially the radial artery in the wrist. Before using this artery, it is important to ensure that there is enough blood flow to the hand to prevent complications. The best way to do this involves the use of ultrasound, but this takes a long time and its availability can be limited. Therefore, the assessment is usually done at the bedside by examining the hand, which relies on the doctor watching the flushing of the hand during compression and release of the artery. Currently, smartphones with cameras are able to assess blood flow by passing light through the skin and observing differences in brightness. This has been shown in a previous study to be a better way to assess the arteries in the hand than the traditional examination, as it is less subjective than simply watching the flushing of the hand. In this study, the investigators will assess the utility of a smartphone application in determining whether there is enough blood flow in the hand prior to using the radial artery for CABG surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 18 years old

• Scheduled to undergo coronary artery bypass graft for which the surgeon is considering the use of a radial artery conduit

• Able and willing to provide written informed consent

Exclusion Criteria:

• Hemodynamic instability

• Need for emergent cardiac surgery

• Known previous removal of the radial or ulnar arteries

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Smartphone assessment
The smartphone app will be performed on participants randomly assigned to receive this test.
• Modified Allen's Test
The modified Allen's test will be will be performed on participants randomly assigned to receive this test.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with use of the radial artery as a conduit for CABG	The primary outcome of this study is the use of the radial artery as a conduit in CABG surgery, which will only occur if the ulnar artery is deemed patent by the corresponding test to which the participant has been randomized to receive (i.e. modified Allen's test or smartphone assessment).	In-hospital (average of 7 days)
Secondary	Number of participants with post-operative hand ischemia	Post-operative hand ischemia as determined by clinical assessment by attending physician or by need for a vascular intervention during index hospital admission.	In-hospital (average of 7 days)
Secondary	Number of participants with early graft failure	Early graft failure as determined by angiography during index hospitalization or by need for rescue percutaneous coronary intervention in the immediate post-operative period	In-hospital (average of 7 days)
Secondary	Number of participants with stroke	Stroke as determined by an attending neurologist	In-hospital (average of 7 days)
Secondary	Number of participants with myocardial infarction	Myocardial infarction as defined by the fourth universal definition of myocardial infarction.	In-hospital (average of 7 days)
Secondary	Number of participants with cardiovascular death	Death from cardiovascular cause as determined by attending physician.	In-hospital (average of 7 days)