ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter

This study is currently recruiting participants.
Verified by University of California, San Francisco, May 2008

Sponsored by: 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

MedlinePlus related topics:   Anesthesia   

ChemIDplus related topics:   Nitroglycerin    Lidocaine    Sorbolene   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter

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 by a direct local action, or by systemic vasodilation. [ Time Frame: June 2008 ] [ Designated as safety issue: No ]

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: June 08 ] [ Designated as safety issue: No ]

Estimated Enrollment:   20
Study Start Date:   May 2008
Estimated Primary Completion Date:   June 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Placebo: Placebo Comparator
Sorbolene cream
Drug: Placebo
Sorbolene cream
Lidocaine: Experimental
Lidocaine 1 inch
Drug: Lidocaine
Visit 2 lidocaine 1 inch + best dose Nitro vs Placebo + lidocaine
Nitro: Experimental
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     Recruiting
      San Francisco, California, United States, 94143
      Contact: Andrew Boyle, MBBS     415-502-1310     aboyle@medicine.ucsf.edu    
      Principal Investigator: Andrew Boyle, MBBS            
      Sub-Investigator: Yerem Yeghiazarians, MD            

Sponsors and Collaborators
University of California, San Francisco
  More Information


Responsible Party:   UCSF ( Dr. Andrew Boyle )
Study ID Numbers:   56438-31921
First Received:   May 19, 2008
Last Updated:   May 28, 2008
ClinicalTrials.gov Identifier:   NCT00686231
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  

Study placed in the following topic categories:
Nitroglycerin
Dilatation, Pathologic
Lidocaine
Healthy

Additional relevant MeSH terms:
Vasodilator Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Cardiovascular Agents
Central Nervous System Agents
Anesthetics, Local
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




Links to all studies - primarily for crawlers