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Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study

Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02519491
Enrollment
438
Registered
2015-08-11
Start date
2015-07-31
Completion date
2018-04-30
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Brief summary

Accessing the arteries of the heart through the blood vessels of the wrist is becoming increasingly popular. By obtaining access via the artery in the arm as opposed to the groin, there is less risk of complications and improved patient satisfaction. However, using the wrist can cause blockage of the artery after the procedure. If there is too little blood flow from a second artery that supplies the hand, this could result in significant injury. Therefore, it is important to test these blood vessels in the wrist prior to having this procedure. The best way to evaluate these arteries involves the use of ultrasounds but this takes a long time and is expensive. Therefore, the artery is usually evaluated with a clinical test known as the modified Allen's test, which relies on the doctor watching the flushing of the hand during compression of the artery. Currently smart phones with cameras are able to assess blood flow by passing light through the skin and watching differences in brightness. This may be a better way to assess the arteries in the hand as it is less subjective than simply watching the flushing of the hand. This study aims to assess the ability of an iPhone application in determining whether there is sufficient blood flow through the arteries of the wrist and comparing it to the clinical test commonly used.

Detailed description

Over the past decade, the transradial approach to cardiac catheterization has emerged as the preferred method of angiography and intervention. There have been several observational and randomized controlled trials which have shown an association between transradial access and reduced risk of bleeding and other vascular complications, increased cost-effectiveness, improved patient satisfaction, and a mortality benefit in high-risk patient populations. However, this technique does carry risks of complications including radial artery occlusion, non-occlusive radial artery injury, radial artery spasm, hand ischemia, pseudoaneurysm, radial artery perforation, nerve damage, arteriovenous fistulisation, and bleeding. Radial artery occlusion is the most commonly noted complication and the clinical impact is unclear. In individuals with intact collateral palmar circulation from the ulnar artery, the individual is usually asymptomatic and do not require further intervention. However, if an individual lacks adequate collateral circulation, that individual is at risk of hand ischemia and loss of tissue or function necessitating surgical intervention or, ultimately, amputation. Thus, it is common practice to assess competency of the collateral palmar circulation prior to transradial cardiac catheterization to mitigate the risks associated with this approach. The gold standard for assessment of radial artery patency is colour Doppler ultrasound imaging of the artery. This gold standard allows for direct, objective assessment of arterial patency and competency through direct visualization of blood flow. The use of pre-procedural ultrasound remains both labour and resource intensive and hence is not feasible for practical use, therefore a physician must rely on clinical assessment of collateral circulation. This has been traditionally evaluated through use of the modified Allen's test (MAT), a technique performed at the bedside as part of the pre-procedural physical examination. More recently, the introduction of plethysmography and pulse oximetry have been utilized to theoretically provide a more objective measure of assessing collateral circulation, though these too are limited by the available resources. Given the ever increasing prevalence of smart phones, this study aims to address the utility and feasibility of an iPhone application in determining adequacy of collateral palmar circulation. Should this iPhone application provide superior diagnostic accuracy, it could quickly become an alternative method of providing an objective measure of collateral palmar circulation rather than relying on the subjective MAT.

Interventions

The Modified Allen's Test (MAT) will be performed in a well-lit room on both of the participant's hands. 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.

OTHERIphone artery assessment

The iRADIAL iPhone 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 thumb and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes.

Sponsors

Ottawa Heart Institute Research Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All persons who are patients at the University of Ottawa Heart Institute and are candidates for coronary angiography.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy1 yearDiagnostic accuracy of the iRADIAL iPhone application in assessing competency of the collateral blood supply to the hand by comparing the results of the iPhone application to the gold standard (i.e. Doppler ultrasound)

Countries

Canada

Participant flow

Participants by arm

ArmCount
Modified Allen's Test
The Modified Allen's Test to assess radial and ulnar patency. Modified Allen Test: The Modified Allen's Test (MAT) will be performed in a well-lit room on both of the participant's hands. 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.
219
Iphone Assessment
iPhone assessment of radial and ulnar patency. Iphone artery assessment: The iRADIAL iPhone 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 thumb and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes.
219
Total438

Baseline characteristics

CharacteristicModified Allen's TestIphone AssessmentTotal
Age, Continuous65.6 years
STANDARD_DEVIATION 13.2
67.0 years
STANDARD_DEVIATION 12.5
66.3 years
STANDARD_DEVIATION 12.8
Ethnicity (NIH/OMB)
Hispanic or Latino
20 Participants11 Participants31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
199 Participants208 Participants407 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
83 Participants70 Participants153 Participants
Sex: Female, Male
Male
136 Participants149 Participants285 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2190 / 219
other
Total, other adverse events
0 / 2190 / 219
serious
Total, serious adverse events
0 / 2190 / 219

Outcome results

Primary

Diagnostic Accuracy

Diagnostic accuracy of the iRADIAL iPhone application in assessing competency of the collateral blood supply to the hand by comparing the results of the iPhone application to the gold standard (i.e. Doppler ultrasound)

Time frame: 1 year

Population: Intention to treat

ArmMeasureValue (NUMBER)
Modified Allen's TestDiagnostic Accuracy81.7 Overall diagnostic accuracy (%)
Iphone AssessmentDiagnostic Accuracy91.8 Overall diagnostic accuracy (%)

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026