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The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology.
Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using the same AD device and operator.
Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AngioDefender | Experimental | The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AngioDefender | Device | Repeatability will be assessed by repeat AngioDefender (AD) testing of the same subject 1 hour apart, using the same AD device and operator. Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline %flow-mediation dilation (%FMD) at 1 hour | Repeat AD testing of the same subject 1 hour apart on 4 consecutive days (operators and/or AD devices change each day) | Daily x 4 consecutive days |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of multiple %FMD determinations by AngioDefender | Repeat AD testing of the same subject over 4 consecutive days using different operators and/or AD devices each day | Daily x 4 consecutive days |
| Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter F Lenehan, MD PhD | Everist Genomics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Western Ontario | London | Ontario | N6A 5A5 | Canada | ||
| Hotel-Dieu Grace Healthcare |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
Spontaneous ADEs reported by the subject and inquiry into emergence of expected/unexpected ADEs |
| 4 consecutive days (maximum 5 days) |
| Windsor |
| Ontario |
| N9C 3Z4 |
| Canada |