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OpenTrials
Completed

NCT Number: NCT03810729

Smartphone Assessment Prior Radial Artery Harvesting for CABG

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone assessment

Diagnostic Test

The smartphone app will be performed on participants randomly assigned to receive this test.

Modified Allen's Test

Diagnostic Test

The modified Allen's test will be will be performed on participants randomly assigned to receive this test.

Primary outcomes

  1. Number of participants with use of the radial artery as a conduit for CABG

    Time frame: In-hospital (average of 7 days)

    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 outcomes

  1. Number of participants with post-operative hand ischemia

    Time frame: In-hospital (average of 7 days)

    Post-operative hand ischemia as determined by clinical assessment by attending physician or by need for a vascular intervention during index hospital admission.

  2. Number of participants with early graft failure

    Time frame: In-hospital (average of 7 days)

    Early graft failure as determined by angiography during index hospitalization or by need for rescue percutaneous coronary intervention in the immediate post-operative period

  3. Number of participants with stroke

    Time frame: In-hospital (average of 7 days)

    Stroke as determined by an attending neurologist

  4. Number of participants with myocardial infarction

    Time frame: In-hospital (average of 7 days)

    Myocardial infarction as defined by the fourth universal definition of myocardial infarction.

  5. Number of participants with cardiovascular death

    Time frame: In-hospital (average of 7 days)

    Death from cardiovascular cause as determined by attending physician.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: iRADIAL-CABG

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2019
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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