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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

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ClinicalTrials.gov Identifier: NCT00686231
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : July 22, 2010
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Condition Healthy
Interventions Drug: Nitroglycerin
Drug: Placebo
Drug: Lidocaine
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Lidocaine Nitro
Hide Arm/Group Description Sorbolene cream Lidocaine 1 inch 1 inch / 2 inches of Nitroglycerin applied topically to the wrist
Period Title: Overall Study
Started 20 20 20
Completed 20 20 20
Not Completed 0 0 0
Arm/Group Title Placebo Lidocaine Nitro Total
Hide Arm/Group Description Sorbolene cream Lidocaine 1 inch 1 inch / 2 inches of Nitroglycerin applied topically to the wrist Total of all reporting groups
Overall Number of Baseline Participants 19 19 19 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 19 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
19
 100.0%
19
 100.0%
57
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 19 participants 57 participants
29  (4) 29  (4) 29  (4) 29  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 19 participants 57 participants
Female
13
  68.4%
13
  68.4%
13
  68.4%
39
  68.4%
Male
6
  31.6%
6
  31.6%
6
  31.6%
18
  31.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 19 participants 57 participants
19 19 19 57
1.Primary Outcome
Title To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery.
Hide Description Diameter of radial artery
Time Frame November 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Lidocaine Nitro
Hide Arm/Group Description:
Sorbolene cream
Lidocaine 1 inch
1 inch / 2 inches of Nitroglycerin applied topically to the wrist
Overall Number of Participants Analyzed 19 19 19
Mean (Standard Deviation)
Unit of Measure: mm
0.2  (0.7) 0.1  (0.3) 0.7  (0.7)
2.Secondary Outcome
Title To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization.
Hide Description Radial artery diameter
Time Frame November 2009
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lidocaine Nitro
Hide Arm/Group Description Sorbolene cream Lidocaine 1 inch 1 inch / 2 inches of Nitroglycerin applied topically to the wrist
All-Cause Mortality
Placebo Lidocaine Nitro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lidocaine Nitro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Lidocaine Nitro
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
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
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00686231     History of Changes
Other Study ID Numbers: 56438-31921
First Submitted: May 19, 2008
First Posted: May 29, 2008
Results First Submitted: November 12, 2009
Results First Posted: July 22, 2010
Last Update Posted: July 22, 2013