Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 BA occlusion by a standard upper arm sphygmomanometric blood pressure (BP) cuff. The procedure is non-invasive and employs neither ultrasound nor Doppler flow analysis. |
|
| Brachial Artery Ultrasound Imaging | Active Comparator | A non-invasive procedure for detecting endothelial dysfunction by measuring the flow-mediated dilation of the brachial artery (BA) using high resolution continuous ECG-gated B-mode (2D) ultrasound imaging during reactive hyperemia, a state of transient increase in tissue blood flow that occurs following a brief period of ischemia, e.g., BA occlusion. BA diameter is measured at end-diastole, coincident with the R wave of a simultaneously recorded ECG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AngioDefender | Device |
| ||
| Ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI) | Deming regression analysis and Bland-Altman Plots | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of types and incidences of emergent adverse device effects | 1 day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter F Lenehan, MD PhD | Everist Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Boulder | Boulder | Colorado | 80303 | United States | ||
| Yale University Prevention Research Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Derby |
| Connecticut |
| 06418 |
| United States |
| Boston University | Boston | Massachusetts | 02118 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| University of Western Ontario | London | Ontario | N6A 5A5 | Canada |