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

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ClinicalTrials.gov Identifier: NCT03810729
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diagnostic Test: Smartphone assessment Diagnostic Test: Modified Allen's Test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Utility of a Smartphone Application in Assessing Palmar Circulation Prior to Radial Artery Harvesting for Coronary Artery Bypass Grafting
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Modified Allen's Test
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.
Diagnostic Test: Modified Allen's Test
The modified Allen's test will be will be performed on participants randomly assigned to receive this test.

Active Comparator: Smartphone assessment
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.
Diagnostic Test: Smartphone assessment
The smartphone app will be performed on participants randomly assigned to receive this test.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810729


Contacts
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Contact: Benjamin Hibbert, MD PhD 613-696-7280 bhibbert@ottawaheart.ca
Contact: Vincent Chan, MD MPH 613-696-7294 vchan@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Benjamin Hibbert, MD PhD    613-696-7280    bhibbert@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Benjamin Hibbert, MD PhD Ottawa Heart Institute Research Corporation
Principal Investigator: Vincent Chan, MD MPH Ottawa Heart Institute Research Corporation
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03810729    
Other Study ID Numbers: 20180865-01H
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Heart Institute Research Corporation:
Smartphone
Coronary artery bypass grafting
Modified Allen's Test
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases