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Smartphone Assessment Prior Radial Artery Harvesting for CABG (iRADIAL-CABG)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Smartphone assessment
Modified Allen's Test
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Coronary Artery Disease focused on measuring Smartphone, Coronary artery bypass grafting, Modified Allen's Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Modified Allen's Test

Smartphone assessment

Arm Description

The Modified Allen's Test (MAT) will be performed in a well-lit room on the participant's hand. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery.

The smartphone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's index finger and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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
Number of participants with stroke
Stroke as determined by an attending neurologist
Number of participants with myocardial infarction
Myocardial infarction as defined by the fourth universal definition of myocardial infarction.
Number of participants with cardiovascular death
Death from cardiovascular cause as determined by attending physician.

Full Information

First Posted
January 14, 2019
Last Updated
October 7, 2022
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03810729
Brief Title
Smartphone Assessment Prior Radial Artery Harvesting for CABG
Acronym
iRADIAL-CABG
Official Title
Utility of a Smartphone Application in Assessing Palmar Circulation Prior to Radial Artery Harvesting for Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Smartphone, Coronary artery bypass grafting, Modified Allen's Test

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Allen's Test
Arm Type
Active Comparator
Arm Description
The Modified Allen's Test (MAT) will be performed in a well-lit room on the participant's hand. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery.
Arm Title
Smartphone assessment
Arm Type
Active Comparator
Arm Description
The smartphone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's index finger and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes.
Intervention Type
Diagnostic Test
Intervention Name(s)
Smartphone assessment
Intervention Description
The smartphone app will be performed on participants randomly assigned to receive this test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Modified Allen's Test
Intervention Description
The modified Allen's test will be will be performed on participants randomly assigned to receive this test.
Primary Outcome Measure Information:
Title
Number of participants with use of the radial artery as a conduit for CABG
Description
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).
Time Frame
In-hospital (average of 7 days)
Secondary Outcome Measure Information:
Title
Number of participants with post-operative hand ischemia
Description
Post-operative hand ischemia as determined by clinical assessment by attending physician or by need for a vascular intervention during index hospital admission.
Time Frame
In-hospital (average of 7 days)
Title
Number of participants with early graft failure
Description
Early graft failure as determined by angiography during index hospitalization or by need for rescue percutaneous coronary intervention in the immediate post-operative period
Time Frame
In-hospital (average of 7 days)
Title
Number of participants with stroke
Description
Stroke as determined by an attending neurologist
Time Frame
In-hospital (average of 7 days)
Title
Number of participants with myocardial infarction
Description
Myocardial infarction as defined by the fourth universal definition of myocardial infarction.
Time Frame
In-hospital (average of 7 days)
Title
Number of participants with cardiovascular death
Description
Death from cardiovascular cause as determined by attending physician.
Time Frame
In-hospital (average of 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Hibbert, MD PhD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Chan, MD MPH
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data from the CAPITAL iRADIAL-CABG study will be made available upon a reasonable request to the principal investigator.
IPD Sharing Time Frame
Data will be available following publication of our manuscript and will remain available for 10 years after this time.
IPD Sharing Access Criteria
Access will be available upon a reasonable request to the principal investigator.
Citations:
PubMed Identifier
35396289
Citation
Goh CY, Parlow S, Di Santo P, Simard T, Jung R, Ahmed Z, Verreault-Julien L, Kuhar P, Chan V, Al-Atassi T, Toeg H, Bernick J, Wells GA, Ruel M, Hibbert B. Utility of a smartphone application in assessing palmar circulation prior to radial artery harvesting for coronary artery bypass grafting: rationale and design of the randomised CAPITAL iRADIAL-CABG trial. BMJ Open. 2022 Apr 8;12(4):e055580. doi: 10.1136/bmjopen-2021-055580.
Results Reference
derived

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Smartphone Assessment Prior Radial Artery Harvesting for CABG

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