Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nitroglycerin 30mg; Drug: Nitroglycerin 15mg; Drug: Lidocaine 40mg; Drug: Lidocaine 20mg; Drug: Placebo

• Registration Number: NCT00686231
• Lead Sponsor: University of California, San Francisco

Brief Summary

The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects in 2 visits to determine the effect of topical nitroglycerin on radial artery vasodilation. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours.

Detailed Description

During the first study visit, as a dose-optimizing study, each subject will be randomly assigned to one of two Dose-Test arms to receive either 15mg or 30mg of nitroglycerin on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. On the second study visit, the same participants will be randomly assigned to one of two Combination-Test arms to receive bilateral topical application of either 20mg or 40mg of lidocaine; the lidocaine will be applied in combination with 30mg of nitroglycerin on one wrist and in combination with placebo on the other wrist. Measurements of radial artery diameter will be performed as in the first visit.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-11-12
• Results First Submitted QC: 2010-06-23
• Results First Posted: 2010-07-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Willing and able to give written informed consent and comply with study requirements
• Patient who speak English

Exclusion Criteria

• Presence or history of liver, cardiovascular, rheumatologic, cancer or renal disease.
• Current treatment with any vasodilator therapy
• Systolic blood pressure of less than 90 mmHg
• History of radial artery catheterization within the previous year
• Absence of radial artery blood flow in one or both arms
• Pregnancy.
• Active infection
• Staff members of the Cardiac Catheterization Laboratory.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Test 40mg Lidocaine	Lidocaine 40mg	Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2
Combination Test 20mg Lidocaine	Nitroglycerin 30mg	Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2
Dose Test 15mg NTG	Nitroglycerin 15mg	Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1
Combination Test 20mg Lidocaine	Lidocaine 20mg	Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2
Combination Test 20mg Lidocaine	Placebo	Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2
Dose Test 15mg NTG	Placebo	Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1
Dose Test 30mg NTG	Nitroglycerin 30mg	Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1
Dose Test 30mg NTG	Placebo	Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1
Combination Test 40mg Lidocaine	Nitroglycerin 30mg	Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2
Combination Test 40mg Lidocaine	Placebo	Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2

Primary Outcome Measures

Name	Time	Method
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin	Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1	Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process.
Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg)	Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2	Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process. To compare combination of (Lidocaine + Nitroglycerin) or (Lidocaine + placebo), at visit 2, participants randomized to Comparison A received 30mg NTG + 20mg Lidocaine on one wrist, and placebo + 20mg Lidocaine on the other wrist; participants randomized to Comparison B received 30mg Nitroglycerin + 40mg Lidocaine on one wrist, and placebo + 40mg Lidocaine on the other wrist.

Trial Locations

Locations (1)

UCSF Medical Center; 🇺🇸 San Francisco, California, United States