Coronary Artery DiseaseiRADIAL-CABGNCT03810729
Smartphone Assessment Prior Radial Artery Harvesting for CABG
A study testing Smartphone assessment and Modified Allen's Test in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Smartphone assessment and Modified Allen's Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2019to 8 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hemodynamic instability
- Need for emergent cardiac surgery
- Known previous removal of the radial or ulnar arteries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of a Smartphone Application in Assessing Palmar Circulation Prior to Radial Artery Harvesting for Coronary Artery Bypass Grafting
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Smartphone assessment, Modified Allen's Test
- Keywords
- Smartphone, Coronary artery bypass grafting, Modified Allen's Test
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone assessmentDiagnostic test
The smartphone app will be performed on participants randomly assigned to receive this test.
Modified Allen's TestDiagnostic test
The modified Allen's test will be will be performed on participants randomly assigned to receive this test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Smartphone assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: In-hospital (average of 7 days)
Secondary outcomes (5)
Number of participants with post-operative hand ischemia
Post-operative hand ischemia as determined by clinical assessment by attending physician or by need for a vascular intervention during index hospital admission.
Measured: In-hospital (average of 7 days)
Number of participants with early graft failure
Early graft failure as determined by angiography during index hospitalization or by need for rescue percutaneous coronary intervention in the immediate post-operative period
Measured: In-hospital (average of 7 days)
Number of participants with stroke
Stroke as determined by an attending neurologist
Measured: In-hospital (average of 7 days)
Number of participants with myocardial infarction
Myocardial infarction as defined by the fourth universal definition of myocardial infarction.
Measured: In-hospital (average of 7 days)
Number of participants with cardiovascular death
Death from cardiovascular cause as determined by attending physician.
Measured: In-hospital (average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start15 May 2019
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Hibbert, MD PhD, Principal investigator, Ottawa Heart Institute Research CorporationVincent Chan, MD MPH, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810729
- Sponsor's protocol ID
- 20180865-01H
- Acronym
- iRADIAL-CABG
- Status last verified
- Oct 2022
- First submitted
- 14 Jan 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from the CAPITAL iRADIAL-CABG study will be made available upon a reasonable request to the principal investigator.
Publications
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.
PubMed 35396289
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of a Smartphone Application in Assessing Palmar Circulation Prior to Radial Artery Harvesting for Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT03810729
- Acronym / sponsor ID
- iRADIAL-CABG / 20180865-01H
- Conditions
- Coronary Artery Disease
- Keywords
- Smartphone, Coronary artery bypass grafting, Modified Allen's Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Allen's Test | Active comparator | Diagnostic Test: Modified Allen's TestThe 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. |
| Smartphone assessment | Active comparator | Diagnostic Test: Smartphone assessmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Hemodynamic instability
- Need for emergent cardiac surgery
- Known previous removal of the radial or ulnar arteries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone assessmentThe smartphone app will be performed on participants randomly assigned to receive this test. | Diagnostic test | Smartphone assessment |
| Modified Allen's TestThe modified Allen's test will be will be performed on participants randomly assigned to receive this test. | Diagnostic test | Modified Allen's Test |
Primary outcome
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).
5 secondary outcomes
Number of participants with post-operative hand ischemia
Time frame: In-hospital (average of 7 days)
Number of participants with early graft failure
Time frame: In-hospital (average of 7 days)
Number of participants with stroke
Time frame: In-hospital (average of 7 days)
Number of participants with myocardial infarction
Time frame: In-hospital (average of 7 days)
Number of participants with cardiovascular death
Time frame: In-hospital (average of 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 35396289Goh 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.
- Individual participant dataSharing planned: Yes. The data from the CAPITAL iRADIAL-CABG study will be made available upon a reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Hibbert, MD PhD principal investigator
Ottawa Heart Institute Research Corporation
Vincent Chan, MD MPH principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone assessment and Modified Allen's Test in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with use of the radial artery as a conduit for CABG (time frame: In-hospital (average of 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.