Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study
1 other identifier
interventional
438
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedResults Posted
Study results publicly available
May 4, 2021
CompletedFebruary 8, 2023
October 1, 2022
2.8 years
August 4, 2015
October 24, 2019
October 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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)
1 year
Study Arms (2)
Modified Allen's Test
ACTIVE COMPARATORThe Modified Allen's Test to assess radial and ulnar patency.
Iphone assessment
ACTIVE COMPARATORiPhone assessment of radial and ulnar patency.
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.
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.
Eligibility Criteria
You may qualify if:
- All persons who are patients at the University of Ottawa Heart Institute and are candidates for coronary angiography.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7, Canada
Related Publications (1)
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.
PMID: 29615421DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Benjamin Hibbert, Cardiologist
- Organization
- University of Ottawa Heart Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Hibbert, MD, PhD
Ottawa Heart Institute Research Corporation
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
August 11, 2015
Study Start
July 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
February 8, 2023
Results First Posted
May 4, 2021
Record last verified: 2022-10