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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
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Condition: Healthy
Interventions: Drug: Nitroglycerin
Drug: Placebo
Drug: Lidocaine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Sorbolene cream
Lidocaine Lidocaine 1 inch
Nitro 1 inch / 2 inches of Nitroglycerin applied topically to the wrist

Participant Flow:   Overall Study
    Placebo   Lidocaine   Nitro
STARTED   20   20   20 
COMPLETED   20   20   20 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Sorbolene cream
Lidocaine Lidocaine 1 inch
Nitro 1 inch / 2 inches of Nitroglycerin applied topically to the wrist
Total Total of all reporting groups

Baseline Measures
   Placebo   Lidocaine   Nitro   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   19   57 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   19   19   19   57 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 29  (4)   29  (4)   29  (4)   29  (4) 
Gender 
[Units: Participants]
       
Female   13   13   13   39 
Male   6   6   6   18 
Region of Enrollment 
[Units: Participants]
       
United States   19   19   19   57 


  Outcome Measures

1.  Primary:   To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery.   [ Time Frame: November 2009 ]

2.  Secondary:   To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization.   [ Time Frame: November 2009 ]
Results not yet reported.   Anticipated Reporting Date:   11/2009  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
a


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew Boyle
Organization: UCSF
phone: 415-514-0827
e-mail: aboyle@medicine.ucsf.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
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: July 17, 2013