Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Modified Allen Test
Iphone artery assessment
Sponsored by
About this trial
This is an interventional screening trial for Coronary Heart Disease
Eligibility Criteria
Inclusion Criteria:
- All persons who are patients at the University of Ottawa Heart Institute and are candidates for coronary angiography.
Exclusion Criteria:
- None
Sites / Locations
- University of Ottawa Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Modified Allen's Test
Iphone assessment
Arm Description
The Modified Allen's Test to assess radial and ulnar patency.
iPhone assessment of radial and ulnar patency.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02519491
First Posted
August 4, 2015
Last Updated
October 12, 2022
Sponsor
Ottawa Heart Institute Research Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02519491
Brief Title
Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study
Official Title
Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Allen's Test
Arm Type
Active Comparator
Arm Description
The Modified Allen's Test to assess radial and ulnar patency.
Arm Title
Iphone assessment
Arm Type
Active Comparator
Arm Description
iPhone assessment of radial and ulnar patency.
Intervention Type
Other
Intervention Name(s)
Modified Allen Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Iphone artery assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic Accuracy
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All persons who are patients at the University of Ottawa Heart Institute and are candidates for coronary angiography.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Hibbert, MD, PhD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
29615421
Citation
Di Santo P, Harnett DT, Simard T, Ramirez FD, Pourdjabbar A, Yousef A, Moreland R, Bernick J, Wells G, Dick A, Le May M, Labinaz M, So D, Motazedian P, Jung RG, Chandrasekhar J, Mehran R, Chong AY, Hibbert B. Photoplethysmography using a smartphone application for assessment of ulnar artery patency: a randomized clinical trial. CMAJ. 2018 Apr 3;190(13):E380-E388. doi: 10.1503/cmaj.170432.
Results Reference
derived
Learn more about this trial
Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study
We'll reach out to this number within 24 hrs