Trial Outcomes & Findings for Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study (NCT NCT02519491)
NCT ID: NCT02519491
Last Updated: 2023-02-08
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
438 participants
Primary outcome timeframe
1 year
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
219
|
219
|
|
Overall Study
COMPLETED
|
219
|
219
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study
Baseline characteristics by cohort
| Measure |
Modified Allen's Test
n=219 Participants
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.
|
Iphone Assessment
n=219 Participants
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.
|
Total
n=438 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
199 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
407 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intention to treat
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)
Outcome measures
| Measure |
Modified Allen's Test
n=219 Participants
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.
|
Iphone Assessment
n=219 Participants
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.
|
|---|---|---|
|
Diagnostic Accuracy
|
81.7 Overall diagnostic accuracy (%)
Interval 76.0 to 86.6
|
91.8 Overall diagnostic accuracy (%)
Interval 87.3 to 95.1
|
Adverse Events
Modified Allen's Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Iphone Assessment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Benjamin Hibbert, Cardiologist
University of Ottawa Heart Institute
Phone: 613-696-7000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place