Smartphone Assessment Prior Radial Artery Harvesting for CABG

NCT03810729 | Completed

• 1 other identifier: 20180865-01H
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Smartphone; Coronary artery bypass grafting; Modified Allen's Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of participants with post-operative hand ischemia

  In-hospital (average of 7 days)

• Number of participants with early graft failure

  In-hospital (average of 7 days)

• Number of participants with stroke

  In-hospital (average of 7 days)

• Number of participants with myocardial infarction

  In-hospital (average of 7 days)

• Number of participants with cardiovascular death

  In-hospital (average of 7 days)

Study Arms (2)

Modified Allen's Test

ACTIVE COMPARATOR

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

Smartphone assessment

ACTIVE COMPARATOR

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

Interventions

Smartphone assessment DIAGNOSTIC_TEST

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

Smartphone assessment

Modified Allen's Test DIAGNOSTIC_TEST

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

Modified Allen's Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hemodynamic instability
• Need for emergent cardiac surgery
• Known previous removal of the radial or ulnar arteries

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (1)

• 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.

  PMID: 35396289 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Benjamin Hibbert, MD PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Vincent Chan, MD MPH

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 22, 2019
• Study Start: May 15, 2019
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available following publication of our manuscript and will remain available for 10 years after this time.
• Access Criteria: Access will be available upon a reasonable request to the principal investigator.

Locations

CA (1)