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Completed

NCT Number: NCT00686231

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

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCSF Medical Center

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitroglycerin 15mg

Drug

15mg Nitroglycerin applied topically to one wrist

Nitroglycerin 30mg

Drug

30mg Nitroglycerin applied topically to one wrist

Lidocaine 20mg

Drug

20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo

Lidocaine 40mg

Drug

40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo

Placebo

Drug

Topical skin moisturizing cream with same appearance as active agent

Other names: skin moisturizing cream

Primary outcomes

  1. Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin

    Time frame: 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.

  2. Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 29, 2008
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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