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Radial Artery Vasodilation Heat Study

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ClinicalTrials.gov Identifier: NCT03620383
Recruitment Status : Completed
First Posted : August 8, 2018
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ramsey Al-Hakim, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Radial Artery Procedure: Topical Heat Phase 1 Phase 2

Detailed Description:
The study will be designed to detect a significant increase in the radial artery diameter of healthy volunteers after the application of a warm heat pack in the palmar aspect of the hand compared to a control group without heat applied to the hand. Employees and students at OHSU will be considered for enrollment as volunteers for this minimal risk study. Informed consent will be obtained from healthy volunteers prior to enrollment. After enrollment, the healthy volunteers will be randomly assigned in a 2:1 ratio to the heat group (Group 1) or the control group (Group 2), respectively. A brief medical history will be obtained from all volunteers, including age, sex, medications, prior interventions, prior surgeries, previous medical diagnoses, allergies, and any history of prior transradial procedures. For protection of confidential health information, brief medical history will be obtained in a private area. The volunteers will then be seated and the left hand placed supinated in a comfortable position on a table. A limited ultrasound of the left radial artery will be performed using grayscale ultrasound. A skin mark will be made with a marker to identify the measurement site. All volunteers will then be given a commercially available warm heat pack and asked to hold gently in their left hand. For the control group (Group 2), the warm heat pack will not be activated. For the heat group (Group 1), the warm heat back will be activated prior to placing in the volunteer's hand. Two investigators will be present. One investigator will be measuring radial artery diameter and will not be aware if the heat pack is activated. The second investigator will be aware of the volunteer's randomly assigned group and will activate the heat pack for the volunteer if they are assigned to Group 1. Over a period of 20 minutes, repeat ultrasound of the left radial artery will be performed in 5 minute intervals.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Radial Artery Vasodilation With Distal Topical Heat Study
Actual Study Start Date : August 3, 2018
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 18, 2018

Arm Intervention/treatment
Experimental: Heat
Distal topical heat application
Procedure: Topical Heat
Warm heat pack applied topically in participant hand.

No Intervention: No Heat
Inactive heat pack to blind the investigator.



Primary Outcome Measures :
  1. Radial Artery Cross Sectional Area [ Time Frame: 20 minutes after application of topical heat ]
    Radial artery cross sectional area after 20 minutes with or without heat application



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers who are 18-99 years old

Exclusion Criteria:

  • Prior left transradial access for procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620383


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Ramsey Al-Hakim, MD Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Ramsey Al-Hakim, Oregon Health and Science University:
Study Protocol  [PDF] August 27, 2019
Statistical Analysis Plan  [PDF] August 27, 2019

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Responsible Party: Ramsey Al-Hakim, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03620383    
Other Study ID Numbers: STUDY00018794
First Posted: August 8, 2018    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramsey Al-Hakim, Oregon Health and Science University:
Transradial access
Radial artery
Vasodilation
Heat