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Radial Artery Vasodilation Heat Study
Phase 1, PHASE2 trial testing Topical Heat in Radial Artery in 45 participants. Completed in 18 September 2018.
| Lead sponsor | Oregon Health and Science University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 3 August 2018 |
| Primary completion | 17 September 2018 |
| Estimated completion | 18 September 2018 |
| Sites | 1 location across United States |
Oregon Health and Science University
Adults 18 to 99, any sex, with Radial Artery. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Radial artery cross sectional area after 20 minutes with or without heat application
| Group | Value | 95% CI |
|---|---|---|
| Heat | 3.4 | ± 1.3 |
| No Heat | 3.0 | ± 1.2 |
The purpose of this study is to collect data about the efficacy of utilizing distal topical heat application for dilatation of the radial artery. Transradial arterial access is widely accepted as the standard of care for cardiac catheterization procedures due to its increased patient comfort and significantly decreased risk of major vascular complications, and has been recently utilized in increasing volume by the interventional radiology community throughout the world. Due to the small size of the radial artery, catheterization may sometimes be technically difficult. Pre-procedure dilatation can make catheterization significantly easier, and studies have demonstrated the successful ability to dilate the radial artery with the use of topical nitroglycerin and lidocaine. However, the investigators hypothesize that utilizing topical heat applied distally can create a physiologic vasodilatation similar to that created with nitroglycerin and lidocaine, but at a significantly lower cost and with less risk due to no need for application of a medication which has a systemic effect with known side effects. The purpose of this study is to test the efficacy of radial artery vasodilatation with distal topical heat application.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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