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

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00686231

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Nitroglycerin Drug: Placebo Drug: Lidocaine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Official Title:	The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter

Resource links provided by NLM:

Drug Information available for: Nitroglycerin Lidocaine

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery. [ Time Frame: November 2009 ] [ Designated as safety issue: No ]
Diameter of radial artery

Secondary Outcome Measures:

To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization. [ Time Frame: November 2009 ] [ Designated as safety issue: No ]
Radial artery diameter

Enrollment:	19
Study Start Date:	May 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Sorbolene cream	Drug: Placebo Sorbolene cream
Experimental: Lidocaine Lidocaine 1 inch	Drug: Lidocaine Visit 2 lidocaine 1 inch + best dose Nitro vs Placebo + lidocaine
Experimental: Nitro 1 inch / 2 inches of Nitroglycerin applied topically to the wrist	Drug: Nitroglycerin 1 inch of Nitroglycerin vs 2 inches of Nitroglycerin

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686231

Locations

United States, California
UCSF Medical Center
San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

More Information

No publications provided

Responsible Party:	Dr. Andrew Boyle, UCSF
ClinicalTrials.gov Identifier:	NCT00686231 History of Changes
Other Study ID Numbers:	56438-31921
Study First Received:	May 19, 2008
Results First Received:	November 12, 2009
Last Updated:	June 23, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation
To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization

Additional relevant MeSH terms:

Nitroglycerin
Lidocaine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 12, 2012