Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Nitroglycerin (Drug); Placebo (Drug); Lidocaine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of California, San Francisco
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 to determine the effect of topical nitroglycerin on
radial artery vasodilation. In the first phase of the study, which is a dose escalation
study, each subject will receive either one or two inches of nitroglycerin in a blinded
manner on one wrist and placebo on the other. Radial artery diameter will be measured with
ultrasound at regular intervals up to two hours. The subjects will then return at a later
date at which point they will receive the alternate dose on one wrist and placebo on the
other. In the second phase of the study, we will randomize the same patients to a mixture of
topical nitroglycerin and lidocaine or topical lidocaine alone. Measurements of radial
artery diameter will be performed as in the first study.
Clinical Details
Official title: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Primary outcome: To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery.
Secondary outcome: To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
UCSF Medical Center, San Francisco, California 94143, United States
Additional Information
Starting date: May 2008
Last updated: July 17, 2013
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