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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00686231
First received: May 19, 2008
Last updated: July 17, 2013
Last verified: July 2013

May 19, 2008
July 17, 2013
May 2008
December 2008   (final data collection date for primary outcome measure)
To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery. [ Time Frame: November 2009 ] [ Designated as safety issue: No ]
Diameter of radial artery
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 ]
Complete list of historical versions of study NCT00686231 on ClinicalTrials.gov Archive Site
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
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 ]
Not Provided
Not Provided
 
Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
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 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Healthy
  • Drug: Nitroglycerin
    1 inch of Nitroglycerin vs 2 inches of Nitroglycerin
  • Drug: Placebo
    Sorbolene cream
  • Drug: Lidocaine
    Visit 2 lidocaine 1 inch + best dose Nitro vs Placebo + lidocaine
  • Placebo Comparator: Placebo
    Sorbolene cream
    Intervention: Drug: Placebo
  • Experimental: Lidocaine
    Lidocaine 1 inch
    Intervention: Drug: Lidocaine
  • Experimental: Nitro
    1 inch / 2 inches of Nitroglycerin applied topically to the wrist
    Intervention: Drug: Nitroglycerin
Majure DT, Hallaux M, Yeghiazarians Y, Boyle AJ. Topical nitroglycerin and lidocaine locally vasodilate the radial artery without affecting systemic blood pressure: a dose-finding phase I study. J Crit Care. 2012 Oct;27(5):532.e9-13. doi: 10.1016/j.jcrc.2012.04.019. Epub 2012 Jun 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00686231
56438-31921
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Not Provided
University of California, San Francisco
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP