Radial Artery Vasodilation Heat Study

NCT03620383 | Completed Phase 1 Results

• 1 other identifier: STUDY00018794
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radial Artery

Keywords

Transradial access; Radial artery; Vasodilation; Heat

Outcome Measures

Primary Outcomes (1)

• Radial Artery Cross Sectional Area

  Radial artery cross sectional area after 20 minutes with or without heat application

  20 minutes after application of topical heat

Study Arms (2)

Heat

EXPERIMENTAL

Distal topical heat application

Procedure: Topical Heat

No Heat

NO INTERVENTION

Inactive heat pack to blind the investigator.

Interventions

Topical Heat PROCEDURE

Warm heat pack applied topically in participant hand.

Heat

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers who are 18-99 years old

You may not qualify if:

• Prior left transradial access for procedure

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Hot Temperature

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Ramsey Al-Hakim, MD
• Organization: Oregon Health & Science University

alhakim@ohsu.edu

503-494-7660

Study Officials

• Ramsey Al-Hakim, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: August 3, 2018
• Primary Completion: September 17, 2018
• Study Completion: September 18, 2018
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-08

Locations

US (1)