Treatment for Coronary Artery Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Ottawa Heart Institute, Ottawa, Canada
Coronary Artery Disease
Eligibility
18+
All Sexes
Eligible conditions
Coronary Artery Disease

Study Summary

This study is evaluating whether a smartphone application can be used to assess the blood flow in the hand prior to using the radial artery for CABG surgery.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Coronary Artery Disease. Measurement will happen over the course of In-hospital (average of 7 days).

Day 7
Number of participants with cardiovascular death
Number of participants with early graft failure
Number of participants with myocardial infarction
Number of participants with post-operative hand ischemia
Number of participants with stroke
Number of participants with use of the radial artery as a conduit for CABG

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Smartphone assessment

This trial requires 236 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Smartphone assessment
DiagnosticTest
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.
Modified Allen's Test
DiagnosticTest
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: in-hospital (average of 7 days)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly in-hospital (average of 7 days) for reporting.

Closest Location

University of Ottawa Heart Institute - Ottawa, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Coronary Artery Disease by sharing your contact details with the study coordinator.