Phase 2
N=45
Radial Artery Vasodilation Heat Study
Radial Artery
Bottom Line
View on ClinicalTrials.gov: NCT03620383 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Radial Artery Cross Sectional Area — 3.4; 3.0 mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Topical Heat (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radial Artery Cross Sectional Area |
3.4; 3.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Volunteers who are 18-99 years old
Exclusion Criteria
- Prior left transradial access for procedure
Data sourced from ClinicalTrials.gov (NCT03620383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.