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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Diagnostic Test: Smartphone assessment Diagnostic Test: Modified Allen's Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|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|
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.
- 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).
- 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.
- 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
- Number of participants with stroke [ Time Frame: In-hospital (average of 7 days) ]Stroke as determined by an attending neurologist
- 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.
- Number of participants with cardiovascular death [ Time Frame: In-hospital (average of 7 days) ]Death from cardiovascular cause as determined by attending physician.
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
|Contact: Benjamin Hibbert, MD PhDfirstname.lastname@example.org|
|Contact: Vincent Chan, MD MPHemail@example.com|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y4W7|
|Contact: Benjamin Hibbert, MD PhD 613-696-7280 firstname.lastname@example.org|
|Principal Investigator:||Benjamin Hibbert, MD PhD||Ottawa Heart Institute Research Corporation|
|Principal Investigator:||Vincent Chan, MD MPH||Ottawa Heart Institute Research Corporation|