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

Tracking Information
First Received Date ^ICMJE	May 19, 2008
Last Updated Date	December 19, 2008
Start Date ^ICMJE	May 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 28, 2008)	To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation. [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00686231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 28, 2008)	To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization. [ Time Frame: June 08 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Official Title ^ICMJE	The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
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 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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Other, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Nitroglycerin Drug: Placebo Drug: Lidocaine
Study Arms / Comparison Groups	Placebo Comparator: Sorbolene cream Experimental: Lidocaine 1 inch Experimental: 1 inch / 2 inches of Nitroglycerin applied topically to the wrist
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	20
Completion Date
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 35 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00686231
Responsible Party	Dr. Andrew Boyle, UCSF
Study ID Numbers ^ICMJE	56438-31921
Study Sponsor ^ICMJE	University of California, San Francisco
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	University of California, San Francisco
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP